December 2014 recalls

1,028 recalls were announced in December 2014.

What the numbers show

Critical: 72
Severe: 272
High: 309
Moderate: 311
Low: 64

Of the 1,028 recalls this month scored against our rubric, 7% are Critical, 26% are Severe.

Which agencies issued them

301–400 of 1028

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-0654-2015·2014-12-24
Stryker Endoscopy Recalls Tissue Grasper Forceps Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of tissue grasper forceps because the instructions for use do not support two specific sterilization methods.
Product
PKG, GRASPER FORCEPS, TISSUE, P/N 0250080284. 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 a
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0300-2015·2014-12-24
Mercaptopurine Tablets Recalled for Failed Dissolution Test Requirements
American Health Packaging is recalling specific lots of Mercaptopurine Tablets, 50 mg, because they failed USP dissolution test requirements.
Product
Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories Inc. 9410 Carroll Park Drive, San Diego, CA 92121, repackaged by American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217, NDC 680
Category
Drug
Distribution
Distributed nationwide
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 frequency
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 whic
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 a
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0693-2015·2014-12-24
Stryker Laparoscopic Forceps Recalled Due to 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, 45CM, P/N 0250080351. 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 wh
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0652-2015·2014-12-24
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 0250080282. 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 w
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 whic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0706-2015·2014-12-24
Stryker Laparoscopic Forceps Recalled for Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 laparoscopic forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, DISSECTING & GRASPER FORCEPS, SERRATED, 45CM, P/N 0250080579 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 rad
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0758-2015·2014-12-24
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, 20CM, P/N 0250282000 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 fr
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) port
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0727-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, ENDO GRASPER, 33CM, P/N 0250080699 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 wh
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0793-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Instruments Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic instruments because the provided instructions do not support specific sterilization methods.
Product
PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 29CM, P/N 0250282101 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 fr
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0710-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Grasper Forceps Due to Sterilization Labeling 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, 5MM INSERT, ATRAUMATIC GRASPER FORCEPS, DOUBLE ACTION 45CM, P/N 0250080585 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 r
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-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 allow
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 them
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 whi
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 t
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-0676-2015·2014-12-24
Stryker Debaney Forceps Recalled Due to Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 units of Debaney Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, DEBANEY FORCEPS, P/N 0250080314. 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-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) port
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0781-2015·2014-12-24
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, 3MM INSERT, SCHERTL GRASPER, FENESTRATED, 29CM, P/N 0250282053 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 frequen
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0702-2015·2014-12-24
Stryker Endoscopy Recalls Mini Metzenbaum Scissors Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of Mini Metzenbaum Scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, MINI METZENBAUM SCISSORS, CURVED, 45CM, P/N 0250080574 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 fre
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0790-2015·2014-12-24
Stryker Dorsey Grasper Recall Due to Sterilization Parameter Errors
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, 29CM, P/N 0250282097 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-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-0629-2015·2014-12-24
Stryker Endoscopy Recalls Babcock Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 Babcock Forceps units because the instructions for use do not support specific sterilization methods.
Product
PKG, BABCOCK FORCEPS, P/N 0250080241. 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 the
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-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 al
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0720-2015·2014-12-24
Stryker Endoscopy Recalls 5mm PEEK Monopolar Handles Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of 5mm PEEK Monopolar Handles because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM PEEK MONOPOLAR HANDLE, P/N 0250080617 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 a
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0733-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, ENDO GRASPER, 45CM, P/N 0250080726 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 wh
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0712-2015·2014-12-24
Stryker Endoscopy Recalls Bowel Grasper Forceps Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 units of Bowel Grasper Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, BOWEL GRASPER FORCEPS, 45CM, P/N 0250080587 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 (R
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0650-2015·2014-12-24
Stryker Dolphin Forceps Recalled for Sterilization Instructions Error
Stryker Endoscopy is recalling Dolphin Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280. 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 (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-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 (R
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 wh
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0820-2015·2014-12-24
Carestream DirectView CR Software Recalled for Reduced Mammographic Image Quality
Carestream Health is recalling 59 units of DirectView CR Software due to reduced image quality when printing true size multi-format images.
Product
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0684-2015·2014-12-24
Stryker Endoscopy Recalls Babcock Forceps Due to Sterilization Documentation Errors
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, P/N 0250080321. 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-0622-2015·2014-12-24
Stryker Laparoscopic Manual Instruments Recalled Due to 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, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231. 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-0675-2015·2014-12-24
Stryker Laparoscopic Forceps Recalled for Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 laparoscopic forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, BLUNT FORCEPS, BLUNT, SERRATED, SPOON, P/N 0250080313. 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-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 which
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 allo
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 (RF)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0747-2015·2014-12-24
Stryker Endoscopy Recalls Allis Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of Allis Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM X 45CM INSERT, ALLIS FORCEPS, DOUBLE ROW TEETH, P/N 0250080754 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 fre
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 which
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0606-2015·2014-12-24
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 0250080009. 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 w
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) po
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 instr
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-0642-2015·2014-12-24
Stryker Endoscopy Recalls Metzenbaum Scissors Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 Metzenbaum Scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, METZENBAUM SCISSORS, STRAIGHT, LONG, P/N 0250080263. 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) p
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0713-2015·2014-12-24
Tastefully Simple Recalls Cookies & Cream Fudge Due to Mold
Tastefully Simple is recalling specific lots of Cookies & Cream Fudge because mold is growing on the chocolate cookie pieces.
Product
Product comes in as part of Fabulous Fudge Gift Box. The Gift box contains 2 samples of the recalled product, Cookies & Cream Fudge and 2 samples of a second product not being recalled. The product comes in small plastic container with lid (3.5" x 2.5" x 21.875"). A small spoon i
Category
Food
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) ports
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0600-2015·2014-12-24
Stryker Myoma Drill Recall Due to Sterilization Instructions
Stryker Endoscopy is recalling Myoma Drill instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, MYOMA DRILL 5MM LENGTH 320MM, P/N 0250080133 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 whic
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 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 which
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 radio
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0633-2015·2014-12-24
Stryker Laparoscopic Claw Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic claw forceps units because the instructions for use do not support specific sterilization methods.
Product
PKG, CLAW FORCEPS, DOUBLE ACTION, P/N 0250080245. 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 w
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 (RF)
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0689-2015·2014-12-24
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, STRIAGHT, P/N 0250080340. 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 al
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0745-2015·2014-12-24
Stryker Laparoscopic Scissors Recalled Due to Sterilization Instructions Error
Stryker Endoscopy is recalling Metzenbaum curved scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM X 45CM, INSERT, METZENBAUM CURVED SCISSORS, LONG JAW, P/N 0250080752 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 rad
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0804-2015·2014-12-24
AGFA Healthcare Recalls Radiomat M+ NIF Films Due to Coating Artifacts
AGFA Healthcare is recalling 142 units of Radiomat M+ NIF films because the coating may show small bright thin lines when processed.
Product
Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF 10 x 12, Radiomat M+ NIF 25,4CM x 30,5CM
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0632-2015·2014-12-24
Stryker Endoscopy Recalls Claw Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of Claw Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, CLAW FORCEPS, P/N 0250080244. 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 t
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0634-2015·2014-12-24
Stryker Laparoscopic Forceps Recalled for Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 units of OP-VIOPSY Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246. 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 wh
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0666-2015·2014-12-24
Stryker Endoscopy Recalls Palpation Probes Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 palpation probes because the instructions for use do not support specific sterilization methods.
Product
PKG, PALPATION PROBE GRADUATED 5MM 45CM, P/N 0250080136 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) port
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0302-2015·2014-12-24
Eisai Recalls Belviq Tablets Due to Missing or Illegible Labels
Eisai Inc. is recalling 121,680 bottles of Belviq (Lorcaserin HCl) 10 mg tablets because some bottles may lack labels or have illegible lot and expiry dates.
Product
BELVIQ¿ (Lorcaserin HCl) Tablets, 10 mg, 60-count bottle, Rx only, Manufactured by: Arena Pharmaceuticals, GmbH, Zofingen, Switzerland, Distributed by: Elsai Inc., Woodcliff, NJ 07677 NDC 62856-52960.
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0739-2015·2014-12-24
Stryker Fundus Grasper Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling Fundus Grasper Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM, 45CM, INSERT, FUNDUS GRASPER FORCEPS, P/N 0250080735 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 (R
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0819-2015·2014-12-24
Trinity Biotech Captia Syphilis IgM Test Kit Recalled for Stability Failure
Clark Laboratories is recalling the Captia Syphilis IgM Capture Test Kit because it failed to meet its labeled expiry dating during routine stability monitoring.
Product
Trinity biotech Captia (TM) Syphilis IgM Capture Test Kit, Product No./REF 800-935, Test Kit for 96 Determinations, IVD for In Vitro Diagnostic use; an antibody class capture enzyme immunoassay for the detection of IgM antibodies to T. pallidum as an aid to the identification of
Category
Medical Device
Distribution
4 states
LowFDA (Devices)·Z-0826-2015·2014-12-24
Teleflex Recalls Weck Hemoclip Ligating Clips Due to Labeling Error
Teleflex Medical is recalling 3,180 units of Weck Hemoclip Ligating Clips because manufacturing and expiration dates were transposed on the packaging labels.
Product
WECK Hemoclip¿ Traditional Medium Tantalum Ligating Clips. Weck Ligating Clips are intended for use in procedures involving vessels or anatomic structures for which the surgeon determines ligating clips are the best choice.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0732-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, RETENTION GRASPER, 45CM, P/N 0250080725 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) por
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0755-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Instruments Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support two specific sterilization methods.
Product
PKG, 5MM MULTI-FUNCTION PEEK HANDLE, P/N 0250181106 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 wh
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0672-2015·2014-12-24
Stryker Endoscopy Recalls ATRAUMATIC FORCEPS Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of ATRAUMATIC FORCEPS because the provided instructions do not support specific sterilization methods.
Product
PKG, ATRAUMATIC FORCEPS, SINGLE ACTION, P/N 0250080310. 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) port
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0814-2015·2014-12-24
Aesculap Miethke Shunt System Recalled for Missing Patient Labels
Aesculap Inc. is recalling four units of the Miethke Shunt System miniNAV Valve due to missing patient labels. No patient injuries have been reported.
Product
Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum.
Category
Medical Device
Distribution
2 states
LowFDA (Devices)·Z-0660-2015·2014-12-24
Stryker Myoma Drill Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling Myoma Drill instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, MYOMA DRILL 10MM LENGTH 320MM, P/N 0250080134. 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 w
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0697-2015·2014-12-24
Stryker Laparoscopic Manual Instruments Recalled for Sterilization Instructions
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 INSULATED SHAFT 45CM, FOR BIPOLAR FORCEPS, P/N 0250080370. 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 frequen
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0609-2015·2014-12-24
Stryker Laparoscopic Hook Scissors Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of laparoscopic hook scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, HOOK SCISSORS, P/N 0250080020. 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
LowFDA (Devices)·Z-0782-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Graspers Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of laparoscopic graspers because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, BLUNT WITH SPOON, GRASPER, 29CM, P/N 0250282055 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
LowFDA (Devices)·Z-0662-2015·2014-12-24
Stryker Endoscopy Recalls 8mm Trocars Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of 8mm trocars because the instructions for use do not support specific sterilization methods.
Product
PKG, TROCAR, 8MM, PYRAMIDAL TIP, P/N 0250080155. 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 wh
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0763-2015·2014-12-24
Stryker Laparoscopic Needle Nose Forceps Recalled for Sterilization Documentation Error
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, 3MM INSERT, NEEDLE NOSE FORCEPS, 20CM, P/N 0250282005 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) p
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0746-2015·2014-12-24
Stryker Kelly Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of Kelly Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM X 45CM, INSERT, KELLY FORCEPS, P/N 0250080753 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
LowFDA (Devices)·Z-0701-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Instructions
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, HOOK SCISSORS, 45CM, P/N 0250080573 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 w
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0304-2015·2014-12-24
Wockhardt Recalls Metoprolol Succinate Tablets for Dissolution Failure
Wockhardt USA is recalling specific lots of Metoprolol Succinate Extended-Release Tablets because they failed long-term stability testing for dissolution specifications.
Product
Wockhardt Metoprolol Succinate, Extended-Release Tablets USP, 50 mg, a)100-count HDPE bottle (NDC 64679-735-02), b) 4000-count pack (64679-735-08), Manufactured by: Wockhardt Limited, Mumbai, India Distributed by Wockhardt USA LLC. 20 Waterview Blvd. Parsippany, NJ 07054 USA
Category
Drug
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0681-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Grasper Forceps Due to Sterilization Documentation Issues
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, SERRSTED FENESTRATED, P/N 0250080318. 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
SevereNHTSA·14V812000·2014-12-23
Spartan Recalls 2013-2015 Motorhomes Due to Steering Linkage Defect
Spartan Motors is recalling 277 model year 2013-2015 motorhomes and chassis cabs because steering linkage castle nuts may loosen, potentially causing a loss of steering control.
Product
SPARTAN — SPARTAN MM, K3, METROSTAR, K2
Category
Vehicle
Distribution
Distributed nationwide
SevereCPSC·15054·2014-12-23
Keurig Recalls MINI Plus Brewing Systems Due to Burn Hazard
Keurig is recalling MINI Plus Brewing Systems because water can overheat and spray out, causing burns. Consumers should contact Keurig for a free repair.
Product
Keurig® MINI Plus Brewing Systems
Category
Consumer Product
Distribution
Distributed nationwide
SevereNHTSA·14V814000·2014-12-23
Caterpillar Recalls 2015 CT660 and CT681 Trucks for Brake Fire Risk
Caterpillar is recalling 57 model year 2015 CT660 and CT681 trucks because an improperly seated brake diaphragm may cause brake drag and a wheel end fire.
Product
CATERPILLAR — CATERPILLAR CT681, CT660
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·14V816000·2014-12-23
Porsche Recalls 2015 918 Models Due to Front Control Arm Fracture Risk
Porsche is recalling 39 model year 2015 918 vehicles because the front lower control arms may fracture, increasing the risk of a crash.
Product
PORSCHE — PORSCHE 918
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·14V813000·2014-12-23
Elgin Recalls 2014 Street Sweepers Due to Electrical Fire Risk
Elgin is recalling 2014 Eagle and Road Wizard street sweepers because battery and alternator wiring may conduct excessive current, increasing the risk of a fire.
Product
ELGIN — ELGIN ROAD WIZARD, EAGLE
Category
Vehicle
Distribution
Distributed nationwide
LowUSDA FSIS·088-2014·2014-12-23
DaBecca Sliced Uncured Apple Smoked Bacon Recalled for Misbranding
DaBecca is recalling approximately 3,450 pounds of sliced uncured apple smoked bacon because the labels lacked the USDA mark of inspection.
Product
DaBecca LLC — Recall Notification Report 088-2014 (DaBecca Sliced Uncured Apple Smoked Bacon)
Category
Food
Distribution
2 states
SevereUSDA FSIS·087-2014·2014-12-22
BMG Trading Recalls Pork Leg Flank Produced Without Federal Inspection
BMG Trading is recalling approximately 26,108 pounds of pork leg flank products that were produced without the benefit of federal inspection.
Product
Canadian Firm Recalls Pork Products Produced Without Benefit of Inspection
Category
Food
Distribution
1 state
SevereNHTSA·14V811000·2014-12-22
Suzuki Recalls Kizashi and SX4 Models for Shift Selector Defect
Suzuki is recalling 2010-2013 Kizashi and SX4 vehicles because the shift selector can move out of Park without the brake pedal being depressed, increasing crash risk.
Product
SUZUKI — SUZUKI KIZASHI, SX4
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·14E086000·2014-12-22
Shark Recalls Certain RAW Motorcycle Helmets for Impact Failure
Shark is recalling specific RAW motorcycle helmets that failed federal impact attenuation tests, increasing the risk of injury in a crash.
Product
EQUIPMENT:MOTORCYCLE:HELMETS recall
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·14E085000·2014-12-22
Roadhouse Recalls Voss 888CF Motorcycle Helmets for Shell Defect
Roadhouse Distribution is recalling Voss 888CF motorcycle helmets because the shell material failed penetration testing, increasing injury risk in crashes.
Product
EQUIPMENT:MOTORCYCLE:HELMETS recall
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·14V807000·2014-12-22
Navistar Recalls 2013-2015 International WorkStar Trucks for Headlight Wiring Defect
Navistar is recalling 2013-2015 International WorkStar trucks because reversed headlight wiring may reduce light output, increasing crash risk.
Product
INTERNATIONAL — INTERNATIONAL WORKSTAR
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·15714·2014-12-22
James Trading Group Recalls Croker Kids Fleece Hoodies Due to Strangulation Hazard
James Trading Group is recalling Croker Kids GAA Fleece Panel Hoodies because the neck drawstrings pose a strangulation hazard to children.
Product
Kids GAA Fleece Panel Hoodie
Category
Consumer Product
Distribution
Distributed nationwide
LowUSDA FSIS·086-2014·2014-12-22
Abe's Finest Meats Recalls Hickory Smoked Sliced Bacon for Misbranding
Abe's Finest Meats is recalling approximately 80,050 pounds of hickory smoked sliced bacon because the ingredient sodium nitrite is not declared on the label.
Product
Recall Notification Report 086-2014 (Hickory Smoked Sliced Bacon)
Category
Food
Distribution
2 states
SevereNHTSA·14E084000·2014-12-19
ZF Group Recalls 9-Speed Automatic Transmissions Due to Parking Pawl Defect
ZF Group is recalling 9-speed automatic transmissions where a contaminated parking pawl may dislodge, preventing the vehicle from locking in Park and increasing crash risk.
Product
POWER TRAIN:AUTOMATIC TRANSMISSION recall
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·14V803000·2014-12-19
Nissan Recalls 2015 Armada Vehicles for Transmission Parking Defect
Nissan is recalling 2015 Armada vehicles because a transmission defect may prevent the parking pawl from fully engaging, allowing the vehicle to move while in Park.
Product
NISSAN — NISSAN ARMADA
Category
Vehicle
Distribution
Distributed nationwide

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