The Recall Desk

Archive

December 2014 recalls

1,028 recalls were announced in December 2014.

What the numbers show

Critical
72
Severe
319
High
264
Moderate
310
Low
63

Of the 1,028 recalls this month scored against our rubric, 7% are Critical, 31% are Severe.

Which agencies issued them

201–300 of 1028

  • ModerateFDA (Devices)·Z-0715-2015·2014-12-24

    Stryker Laparoscopic Needle Holder Recall Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 laparoscopic needle holders because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM SHAFT, NEEDLE HOLDER, CURVED RIGHT, 45CM, P/N 0250080590 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0623-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Instruments Due to Sterilization Documentation Errors

    Stryker Endoscopy is recalling 180,573 laparoscopic instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, ROTATING HANDLE, RATCHET, INSULATED/SHAFT, P/N 0250080233. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0789-2015·2014-12-24

    Stryker Dorsey Grasper Recall Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 Dorsey Grasper instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, DORSEY GRASPER, 20CM, P/N 0250282096 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0761-2015·2014-12-24

    Stryker Fundus Grasper Recall Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 Fundus Grasper instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, FUNDUS GRASPER, 20CM, P/N 0250282003 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0711-2015·2014-12-24

    Stryker Endoscopy Recalls Babcock Grasper Forceps Due to Sterilization Labeling Error

    Stryker Endoscopy is recalling 180,573 units of Babcock Grasper Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSERT, BABCOCK GRASPER FORCEPS, 45CM, P/N 0250080586 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0791-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Graspers Due to Sterilization Documentation Issues

    Stryker Endoscopy is recalling 180,573 units of laparoscopic atraumatic graspers because the provided instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, ATRAUMATIC GRASPER, SINGLE ACTION, 29CM, P/N 0250282099 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0651-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Issues

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the provided instructions for use do not support specific sterilization methods.

    Product
    PKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080281. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0728-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSERT, PADDLE BABCOCK, 33CM, P/N 0250080700 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0671-2015·2014-12-24

    Stryker Blakesly Biopsy Forceps Recalled Due to Sterilization Instructions

    Stryker Endoscopy is recalling Blakesly Biopsy Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, BLAKESLY BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080293. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0641-2015·2014-12-24

    Stryker Endoscopy Recalls Peritoneal Scissors Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of peritoneal scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, PKG, PERITONEAL SCISSORS, P/N 0250080262. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0692-2015·2014-12-24

    Stryker Endoscopy Recalls Bipolar Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of bipolar forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, BIPOLAR FORCEPS, FENESTRATED, 45CM, P/N 0250080350. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0736-2015·2014-12-24

    Stryker Endoscopy Recalls 3.5mm Pyramidal Trocars Due to Sterilization Labeling Error

    Stryker Endoscopy is recalling 180,573 units of 3.5mm Pyramidal Trocars because the instructions for use do not support specific sterilization methods.

    Product
    PKG, ASSY, 3.5MM PYRAMIDAL TROCAR, LONG P/N 0250080730 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0667-2015·2014-12-24

    Stryker Endoscopy Recalls Bipolar Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of bipolar forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, BIPOLAR FORCEPS, FENESTRATED 45CM, P/N 0250080113. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0690-2015·2014-12-24

    Stryker Laparoscopic Needle Holder Recall Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 laparoscopic needle holders because the instructions for use do not support specific sterilization methods.

    Product
    PKG, NEEDLE HOLDER, CURVED LEFT, P/N 0250080341. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0786-2015·2014-12-24

    Stryker Endoscopy Recalls Biopsy Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of biopsy forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, BIOPSY FORCEPS, 29CM, P/N 0250282059 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0799-2015·2014-12-24

    Teleflex Recalls Sheridan Cuffed Tracheal Tubes Due to Labeling Error

    Teleflex Medical is recalling 14,000 Sheridan/CF Cuffed Tracheal Tubes because the label indicates size 8mm but the tube may be size 7.5mm.

    Product
    Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for oral and nasal intubation and are indicated for airway management.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0679-2015·2014-12-24

    Stryker Endoscopy Recalls Alligator Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of Alligator Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, ALLIGATOR FORCEPS, P/N 0250080316. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0711-2015·2014-12-24

    Odwalla Chocolate Protein Shake Recalled for Potential Spoilage

    Coca-Cola is recalling Odwalla Chocolate Protein Shakes because some bottles may spoil before the expiration date.

    Product
    Odwalla Chocolate Protein Shake, 15.2 fl. oz, and 32 fl. oz bottles, Distributed by: Odwalla, Inc., Dinuba, CA 93618.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0615-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Micro Scissors Due to Sterilization Documentation Issues

    Stryker Endoscopy is recalling 180,573 units of laparoscopic micro scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080029. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0674-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, SCHERTEL FORCEPS, FENESTRATED, P/N 0250080312. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0639-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, PKG, HOOK SCISSORS, P/N 0250080260. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0625-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the provided instructions for use do not support specific sterilization methods.

    Product
    PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0700-2015·2014-12-24

    Stryker Endoscopy Recalls 10mm Clip Applying Forceps Due to Sterilization Documentation

    Stryker Endoscopy is recalling 180,573 units of 10mm Clip Applying Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 10MM CLIP APPLYING FORCEPS, P/N 0250080558. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0778-2015·2014-12-24

    Stryker Endoscopy Recalls Fundus Grasper Instruments Due to Sterilization Labeling Error

    Stryker Endoscopy is recalling 180,573 Fundus Grasper instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, FUNDUS GRASPER, 29CM, P/N 0250282050 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0749-2015·2014-12-24

    Stryker Laparoscopic Dissector Recalled for Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 laparoscopic dissectors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM X 33CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250080757 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0779-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, FUNDUS GRASPER, 29CPKG, 3MM INSERT, ALLIGATOR GRASPER, 29CM, P/N 0250282051 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0687-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Grasper Forceps Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic grasper forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, GRASPER FORCEP, BOWEL, P/N 0250080324. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0721-2015·2014-12-24

    Stryker Endoscopy Recalls 10mm PEEK Monopolar Handle Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of 10mm PEEK Monopolar Handles because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 10MM PEEK MONOPOLAR HANDLE, P/N 0250080618 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0635-2015·2014-12-24

    Stryker Endoscopy Recalls Serrated Operating Scissors Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of Serrated Operating Scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, OPERATING SCISSORS, SERRATED, P/N 0250080247. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0691-2015·2014-12-24

    Stryker Laparoscopic Needle Holder Recall Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 laparoscopic needle holders because the instructions for use do not support specific sterilization methods.

    Product
    PKG, NEEDLE HOLDER, CURVED RIGHT, P/N 0250080342. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0724-2015·2014-12-24

    Stryker Laparoscopic Forceps Recalled Due to Sterilization Instructions Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSERT, RIGHT ANGLE FORCEP, 33CM, P/N 0250080694 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0769-2015·2014-12-24

    Stryker Endoscopy Recalls Maryland Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 Maryland Forceps instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, MARYLAND, FORCEPS CURVED, 20CM, P/N 0250282011 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0753-2015·2014-12-24

    Stryker Johann Forceps Recalled for Sterilization Instructions Error

    Stryker Endoscopy is recalling Johann Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM X 33CM INSERT, JOHANN FORCEPS, P/N 0Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0716-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSERT, ALLIS SINGLE ROW TEETH, P/N 0250080591 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0775-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Scissors Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of Metzenbaum scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, METZENBAUM, CURVED, LONG SCISSORS, 29CM, P/N 0250282047 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0788-2015·2014-12-24

    Stryker Laparoscopic Needleholder Recall Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 laparoscopic needleholders because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, STRAIGHT NEEDLEHOLDER, 29CM, P/N 0250282061 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0688-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the provided instructions for use do not support specific sterilization methods.

    Product
    PKG, MICRO GRASPER, P/N 0250080325. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0645-2015·2014-12-24

    Stryker Mini Metzenbaum Scissors Recalled Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 Mini Metzenbaum Scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, MINI METZENBAUM SCISSORS, CURVED LONG, P/N 0250080266. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0644-2015·2014-12-24

    Stryker Metzenbaum Scissors Recalled Due to Sterilization Instructions Error

    Stryker Endoscopy is recalling Metzenbaum Scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, METZENBAUM SCISSORS, CURVED LONG, P/N 0250080265. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0729-2015·2014-12-24

    Stryker Endoscopy Recalls Endoloop Applicator Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 Endoloop Applicator units because the instructions for use do not support specific sterilization methods.

    Product
    PKG, ENDOLOOP APPLICATOR, P/N 0250080701 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0636-2015·2014-12-24

    Stryker Maryland Forceps Recalled Due to Sterilization Instructions

    Stryker Endoscopy is recalling Maryland Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, MARYLAND FORCEPS, CURVED, P/N 0250080248. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0299-2015·2014-12-24

    Zydus Recalls Benzonatate Capsules Due to Wet or Leaking Capsules

    Zydus Pharmaceuticals is recalling 58,920 bottles of Benzonatate Capsules, 200 mg, because some capsules are wet or leaking.

    Product
    Benzonatate Capsules, USP, 200 mg, 100-count bottles, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: Zydus Pharmaceuticals USA, In, Pennington, NJ USA 08534; NDC 68382-248-01, UPC 3 68382 24801 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0619-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, LUERLOCK, FEMALE, 6MM TUBING, P/N 0250080208. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0762-2015·2014-12-24

    Stryker Endoscopy Recalls 180,573 Alligator Graspers Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of 3mm Alligator Graspers because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, ALLIGATOR GRASPER, 20CM, P/N 0250282004 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0656-2015·2014-12-24

    Stryker Endoscopy Recalls Serrated Grasper Forceps Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of Serrated Grasper Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, GRASPER FORCEPS, SERRATED, P/N 0250080286. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0714-2015·2014-12-24

    Stryker Laparoscopic Needle Holder Recall Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 laparoscopic needle holders because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM SHAFT, NEEDLE HOLDER CURVED LEFT 45CM, P/N 0250080589 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0604-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, OBTURATOR, 5.5MM FOR HASSON CANNULA, P/N 0250080157; Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0756-2015·2014-12-24

    Stryker Laparoscopic Manual Instruments Recalled for Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, ASSY, 5MM PEEK MULTI HANDLE, 45CM, P/N 0250181108 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0768-2015·2014-12-24

    Stryker Endoscopy Recalls Bullet Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of 3mm Bullet Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, BULLET FORCEPS, 20CM, P/N 0250282010 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0620-2015·2014-12-24

    Stryker Maryland Forceps Recalled Due to Sterilization Parameter Errors

    Stryker Endoscopy is recalling Maryland Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, MARYLAND FORCEPS, CURVED, LEFT, P/N 0250080042. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0770-2015·2014-12-24

    Stryker Endoscopy Recalls Biopsy Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of biopsy forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, BIOPSY FORCEPS, 20CM, P/N 0250282012 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0827-2015·2014-12-24

    JAS Diagnostics Recalls Glucose Hexokinase Reagent Due to Performance Issues

    JAS Diagnostics Inc. is recalling 390 units of Glucose Hexokinase (Liquid) Reagent because the product does not perform according to specifications.

    Product
    Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination of Glucose in serum.
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-0694-2015·2014-12-24

    Stryker Laparoscopic Forceps Recalled Due to Sterilization Instructions Error

    Stryker Endoscopy is recalling 180,573 units of bipolar forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080360. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0608-2015·2014-12-24

    Stryker Laparoscopic Forceps Recalled Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 Mixter Forceps units because the instructions for use do not support specific sterilization methods.

    Product
    PKG, MIXTER FORCEPS, P/N 0250080010. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0822-2015·2014-12-24

    Biomet Recalls Sirius Hip Stems Due to Packaging Mix-Up

    Biomet is recalling nine Sirius Femoral Hip Stems because parts were mixed up prior to packaging and shipment.

    Product
    Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented Device Common Name: Sirius Femoral Stem The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0680-2015·2014-12-24

    Stryker Cobra Forceps Recalled Due to Sterilization Instructions Error

    Stryker Endoscopy is recalling Cobra Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, COBRA FORCEPS, P/N 0250080317. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0764-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, SCHERTL GRASPER, FENESTRATED, 20CM, P/N 0250282006 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0772-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Issues

    Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the provided instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, STRAIGHT NEEDLEHOLDER, 20CM, P/N 0250282014 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0627-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling

    Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, SPRING HANDLE, P/N 0250080237. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0696-2015·2014-12-24

    Stryker Endoscopy Recalls Bipolar Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of bipolar forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080362. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0655-2015·2014-12-24

    Stryker Endoscopy Recalls Mixter Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 Mixter Forceps units because the instructions for use do not support specific sterilization methods.

    Product
    PKG, MIXTER FORCEPS, P/N 0250080285. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0707-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Biopsy Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of laparoscopic biopsy forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSERT, BIOPSY FORCEPS, PUNCH, 45CM, P/N 0250080580 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0677-2015·2014-12-24

    Stryker Laparoscopic Manual Instruments Recalled for Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG. MODIFIED 5X33 DEBAKEY, P/N 0250080314S2. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0726-2015·2014-12-24

    Stryker Laparoscopic Instruments Recalled for Sterilization Documentation Issues

    Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSERT, TENACULUM, 33CM, P/N 0250080698 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0731-2015·2014-12-24

    Stryker Endoscopy Recalls Aspiration Needles Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 aspiration needles because the instructions for use do not support specific sterilization methods.

    Product
    PKG, ASPIRATION NEEDLE, 45 CM, P/N 0250080703 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0630-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Grasper Forceps Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic grasper forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, GRASPER FORCEPS, NARROW JAW, P/N 0250080047 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0752-2015·2014-12-24

    Stryker Laparoscopic Forceps Recalled for Sterilization Instructions Error

    Stryker Endoscopy is recalling 180,573 laparoscopic dissecting forceps units because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM X 45CM INSERT, DISSECTING FORCEPS, P/N 0250080762 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0596-2015·2014-12-24

    Stryker Endoscopy Recalls Bipolar Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of bipolar forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0597-2015·2014-12-24

    Stryker Laparoscopic Biopsy Forceps Recalled for Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of OP-Biopsy Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, OP-BIOPSY FORCEPS, SPOON JAW, P/N 0250080007 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0601-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Palpation Probes Due to Sterilization Labeling Error

    Stryker Endoscopy is recalling 180,573 laparoscopic palpation probes because the instructions for use do not support specific sterilization methods.

    Product
    PKG, PALPATION PROBE GRADUATED 5MM, P/N 0250080135; Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0723-2015·2014-12-24

    Stryker 3.5mm Trocar Recalled for Sterilization Instructions Error

    Stryker Endoscopy is recalling 180,573 units of 3.5mm trocars because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3.5MM TROCAR, PYRAMIDAL TIP, SHORT, P/N 0250080692 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0658-2015·2014-12-24

    Stryker Endoscopy Recalls Needle Nose Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of Needle Nose Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, NEEDLE NOSE FORCEPS, P/N 0250080288. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0594-2015·2014-12-24

    Stryker Laparoscopic Forceps Recalled for Sterilization Parameter Errors

    Stryker Endoscopy is recalling 180,573 units of bipolar forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, BIPOLAR FORCEPS, PADDLE, 33CM, P/N 0250080121 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0686-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Grasper Forceps Due to Sterilization Labeling

    Stryker Endoscopy is recalling 180,573 units of atraumatic grasper forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, GRASPER FORCEPS, ATRAUMATIC, P/N 0250080323. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0744-2015·2014-12-24

    Stryker Peritoneal Scissors Recalled Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of 5mm x 45cm Peritoneal Scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM X 45CM, INSERT, PERITONEAL SCISSORS, P/N 0250080751 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0812-2015·2014-12-24

    4-Web Inc. Recalls Mislabeled Anterior Lumbar Spine Truss Systems

    4-Web Inc. is recalling 35 units of Anterior Lumbar Interbody Fusion Spine Truss Systems due to product mislabeling. The affected devices were distributed in six US states and DC.

    Product
    ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-LG0612: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 6 degrees lordosis, 12 mm height
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0780-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Issues

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the provided instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, NEEDLE NOSE FORCEPS, 29CM, P/N 0250282052 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0638-2015·2014-12-24

    Stryker Endoscopy Recalls Babcock Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of Babcock Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, BABCOCK FORCEPS, PADDLE, P/N 0250080250. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0598-2015·2014-12-24

    Stryker Laparoscopic Fixation Clamp Recall Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 laparoscopic fixation clamps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, FIXATION CLAMP 5MM WITH RATCHET, P/N 0250080130 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0648-2015·2014-12-24

    Stryker Laparoscopic Scissors Recalled Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of laparoscopic micro scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080269. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0797-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Issues

    Stryker Endoscopy is recalling laparoscopic manual instruments because the provided instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM X 29CM INSERT, DISSECTING FORCEPS, P/N 0250282110 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0722-2015·2014-12-24

    Stryker Endoscopy Recalls 3.5mm Cannula Packages Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of 3.5mm cannula packages because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3.5MM CANNULA AUTO VALVE, STOPCOCK, SHORT, P/N 0250080634 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0683-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of Strong Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, STRONG FORCEPS, FENESTRATED, P/N 0250080320. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0607-2015·2014-12-24

    Stryker Endoscopy Recalls Hasson Cannula Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 Hasson Cannula units because the instructions for use do not support specific sterilization methods.

    Product
    PKG, HASSON CANNULA, 5.5MM, AUTOMATIC VALVE, STOP COCK, P/N 0250080176. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0653-2015·2014-12-24

    Stryker Kelly Forceps Recalled Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 Kelly Forceps units because the instructions for use do not support specific sterilization methods.

    Product
    PKG, KELLY FORCEPS, CURVED LEFT, P/N 0250080283. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0743-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSERT, 45CM, DEBAKEY FORCEPS, P/N 0250080748 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0704-2015·2014-12-24

    Stryker Endoscopy Recalls Maryland Dissecting Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 Maryland Dissecting Forceps units because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSERT, MARYLAND DISSECTING FORCEPS, CURVED LEFT, 45CM, P/N 00250080578 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0725-2015·2014-12-24

    Stryker Laparoscopic Graspers Recalled for Sterilization Parameter Errors

    Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSERT, RETENTION GRASPER, 33CM, P/N 0250080697 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0640-2015·2014-12-24

    Stryker Laparoscopic Needle Nose Forceps Recalled for Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of laparoscopic needle nose forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, NEEDLE NOSE FORCEPS, P/N 0250080048. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0719-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the provided instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM ROTATING HANDLE, W/RATCHET, INSULATED SHAFT 45CM LENGTH, P/N 0250080596 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0678-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Instruments Due to Sterilization Documentation Issues

    Stryker Endoscopy is recalling 180,573 laparoscopic instruments because the provided instructions do not support specific sterilization methods.

    Product
    PKG, FUNDUS FORCEPS, P/N 0250080315. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0665-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Cannula Packages Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 units of 11mm Laparoscopic Cannula packages because the provided instructions do not support specific sterilization methods.

    Product
    PKG, CANNULA, 11MM, AUTOMATIC VALVE STOP COCK, W/O TROCAR, P/N 0250080174. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0738-2015·2014-12-24

    Stryker Laparoscopic Manual Instruments Recalled for Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSERT, PARK FORCEPS, P/N 0250080733 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0603-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Trocars Due to Sterilization Documentation Issues

    Stryker Endoscopy is recalling 180,573 laparoscopic trocars because the provided instructions for use do not support specific sterilization methods.

    Product
    PKG, TROCAR 5.5MM PYRAMIDAL TIP, P/N 0250080154; Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0647-2015·2014-12-24

    Stryker Endoscopy Recalls Laparoscopic Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of atraumatic forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION, P/N 0250080071. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0741-2015·2014-12-24

    Stryker Endoscopy Recalls Park Forceps Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 units of Park Forceps because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSERT, 45CM, PARK FORCEPS, P/N 0250080745 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0787-2015·2014-12-24

    Stryker Endoscopy Recalls Biopsy Punch Instruments Due to Sterilization Labeling Error

    Stryker Endoscopy is recalling 180,573 biopsy punch instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, BIOPSY PUNCH, 29CM, P/N 0250282060 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0712-2015·2014-12-24

    Odwalla Vanilla Almondo Protein Recalled for Potential Spoilage

    The Coca-Cola Company is recalling Odwalla Vanilla Almondo Protein bottles due to the potential for spoilage before the end of their shelf life.

    Product
    Odwalla Vanilla Almondo Protein, 15.2 fl. oz bottles, Distributed by: Odwalla, Inc., Dinuba, CA 93618.
    Category
    Food
    Distribution
    Distributed nationwide

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