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

201–300 of 1028

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) p
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0713-2015·2014-12-24
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, STRAIGHT, 45CM, P/N 0250080588 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-0668-2015·2014-12-24
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, BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080291. 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-0798-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Instruments Due to Sterilization Labeling Errors
Stryker Endoscopy is recalling 180,573 laparoscopic instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, CANNULA 8MM AUTOMATIC VALVE STOP COCK, W/O TROCAR, P/N 0250080172 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 freq
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 allo
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 wh
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-0698-2015·2014-12-24
Stryker Laparoscopic Forceps Recalled for Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 laparoscopic forceps units because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSULATED SHAFT 33CM, FOR BIPOLAR FORCEPS, P/N 0250080371. 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-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-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 a
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-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 whic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0649-2015·2014-12-24
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, MICRO SCISSORS, CURVED, P/N 0250080270. 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-0785-2015·2014-12-24
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, 3MM INSERT, MARYLAND, FORCEPS CURVED, 29CM, P/N 0250282058 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-0717-2015·2014-12-24
Stryker Laparoscopic Instruments Recalled for Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 laparoscopic instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, ALLIS DOUBLE ROW TEETH, P/N 0250080592 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 allo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0734-2015·2014-12-24
Mexicantown Bakery Recalls Concha Pink Pastries Due to Undeclared Artificial Coloring
Mexicantown Bakery, Inc. is recalling Concha Pink pastries because they contain undeclared artificial coloring agents.
Product
Concha Pink- pastry containing soy, eggs, wheat and FD&C Yellow #5 and #6, and Red #3 and #40.
Category
Food
Distribution
1 state
ModerateFDA (Devices)·Z-0796-2015·2014-12-24
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, 3MM X 29CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250282105 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-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-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 (R
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0742-2015·2014-12-24
Stryker Endoscopy Recalls Park Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling specific Park Forceps instruments because the instructions for use do not support certain 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 wh
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0616-2015·2014-12-24
Stryker Laparoscopic Reducers Recalled for Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 laparoscopic reducers because the instructions for use do not support specific sterilization methods.
Product
PKG, 12.5/11MM - 5.5 REDUCER, P/N 0250080204. 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-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-0643-2015·2014-12-24
Stryker Metzenbaum Scissors Recalled 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, P/N 0250080264. 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-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-0735-2015·2014-12-24
Stryker Endoscopy Recalls 5mm Right Angle Forceps Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of 5mm Right Angle Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, RIGHT ANGLE FORCEP, 45CM P/N 0250080729 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-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-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 (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-0766-2015·2014-12-24
Stryker Laparoscopic Grasper Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic graspers because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, BLUNT WITH SPOON, GRASPER, 20CM, P/N 0250282008 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-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-0734-2015·2014-12-24
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, PADDLE BABCOCK, 45CM, P/N 0250080727 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-0742-2015·2014-12-24
Beachbody Base Shake Recalled for Mislabeling as Fuel Shot
Beachbody is recalling specific lots of Hardcore Base Shake because some bottles were incorrectly labeled as Fuel Shot due to a labeling error at the contract manufacturer.
Product
Beachbody Hardcore Base Shake Lot #42932B22, #42931A22, and #42902B22 Black HDPE container with Black Lid. Label stated weight of 1 lb. 12.2 oz. (800 g.) Lot code information located on the bottom of the container in yellow ink.
Category
Food
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-0685-2015·2014-12-24
Stryker Laparoscopic Grasper Forceps Recalled Due to Sterilization Instructions
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, DELICATE, FENESTRATED, P/N 0250080322. 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-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-0751-2015·2014-12-24
Stryker Laparoscopic Dissector Recall Due to 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 45CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250080761 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-0637-2015·2014-12-24
Stryker Laparoscopic Forceps Recalled for Sterilization Parameter Errors
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 0250080249. 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-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) p
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-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) ports
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) port
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0699-2015·2014-12-24
Stryker Laparoscopic Trocar Recall Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic trocars because the instructions for use do not support specific sterilization methods.
Product
PKG, TROCAR, 12.5MM, PYRAMIDAL TIP, P/N 0250080422. 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-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-0426-2015·2014-12-24
GE Cabinet X-ray Systems Recalled for Performance Standards Non-Compliance
GE Inspection Technologies is recalling 11 cabinet X-ray systems that may fail to comply with performance standards.
Product
GE Cabinet X-ray systems
Category
Medical Device
Distribution
9 states
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-0708-2015·2014-12-24
Stryker Endoscopy Recalls 5mm Insert Biopsy Forceps Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 units of 5mm Insert Biopsy Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT BIOPSY FORCEPS, SPOON W/PIN, 45CM, P/N 0250080581 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-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-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-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 (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 (RF)
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0795-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Instruments Due to Sterilization Labeling Errors
Stryker Endoscopy is recalling 180,573 laparoscopic instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM X 20CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250282104 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-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 whic
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-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) port
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) p
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0624-2015·2014-12-24
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, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080234. 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 frequenc
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-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-0695-2015·2014-12-24
Stryker Laparoscopic Forceps Recalled 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, PADDLE, 33CM, P/N 0250080361. 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-0771-2015·2014-12-24
Stryker Endoscopy Recalls 3mm Biopsy Punch Instruments Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of 3mm Biopsy Punch instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, BIOPSY PUNCH, 20CM, P/N 0250282013 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-0718-2015·2014-12-24
Stryker Laparoscopic Manual Instruments 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 ROTATING HANDLE, INSULATED SHAFT/ HANDLE 45CM LENGTH, P/N 0250080595 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-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 (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-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) por
Category
Medical Device
Distribution
Distributed nationwide
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 (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) port
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0614-2015·2014-12-24
Stryker Baby Metzenbaum Scissors Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 Baby Metzenbaum Scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, BABY METZENBAUM SCISSORS, CURVED, P/N 0250080028. 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-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-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-0595-2015·2014-12-24
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 0250080122 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-0705-2015·2014-12-24
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,5MM 45CM INSERT,PERFORATOR, P/N 0250080578S1 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-0806-2015·2014-12-24
American Medical Systems Recalls AdVance Male Sling Systems Due to Packaging Defects
American Medical Systems is recalling AdVance Male Sling Systems because sterile barrier packaging may fail during extreme shipping and handling.
Product
AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (not commercially available in the US) The AdVance Male Sling System consists of two, sterile single-use surgical instruments called helical needle passers and a mesh sling with attache
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 allow
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-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) port
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0709-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Grasper Forceps Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of 5mm atraumatic grasper forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, ATRAUMATIC GRASPER FORCEPS, SINGLE ACTION, P/N 0250080584 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-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-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-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-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-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-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-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-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 (RF)
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-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-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-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-0737-2015·2014-12-24
Stryker Endoscopy Recalls Fenestrated Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 fenestrated forceps units because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM, 45CM, INSERT, FENESTRATED FORCEPS, P/N 0250080732 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 which
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-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-0593-2015·2014-12-24
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 0250080120 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-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-0776-2015·2014-12-24
Stryker Endoscopy Recalls Laparoscopic Scissors Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 units of laparoscopic scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, PERITONEAL SCISSORS, 29CM, P/N 0250282048 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 (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

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