FDA (Devices) recall action 69838

Stryker Endoscopy recalled 207 products on 2014-12-24

The FDA (Devices) publishes a recall like this one as 207 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 207 pages.

Products: 207
Announced: 2014-12-24
Critical: 0
Units: 37,017,465

Why these products were recalled

The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods

Stryker Endoscopy is recalling Laparoscopic manual instruments and accessories because the parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

126–150 of 207

ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, SCHERTL GRASPER, FENESTRATED, 20CM, P/N 0250282006 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequen
Category
Distribution
2 states
LowFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Maryland Dissecting Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 Maryland Dissecting Forceps units because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, MARYLAND DISSECTING FORCEPS, CURVED LEFT, 45CM, P/N 00250080578 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have
Category
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Laparoscopic Graspers Recalled for Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, RETENTION GRASPER, 33CM, P/N 0250080697 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) por
Category
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Metzenbaum Scissors Recalled Due to Sterilization Instructions
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 0250080025. 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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Park Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of Park Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, 45CM, PARK FORCEPS, P/N 0250080745 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports wh
Category
Distribution
2 states
ModerateFDA (Devices)··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, BIOPSY FORCEPS, PUNCH, P/N 0250080290. 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 all
Category
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Biopsy Punch Instruments Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 biopsy punch instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, BIOPSY PUNCH, 29CM, P/N 0250282060 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports wh
Category
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
LowFDA (Devices)··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
Distribution
2 states
LowFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Laparoscopic Forceps Recalled for Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 laparoscopic dissecting forceps units because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM X 45CM INSERT, DISSECTING FORCEPS, P/N 0250080762 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) p
Category
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states