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

176–200 of 207

ModerateFDA (Devices)··2014-12-24
Stryker Laparoscopic Forceps Recalled for Sterilization Instructions Error
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 0250080311. Laparoscopic Manual Instruments 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 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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Cobra Forceps Recalled Due to Sterilization Instructions Error
Stryker Endoscopy is recalling Cobra Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, COBRA FORCEPS, P/N 0250080317. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them t
Category
Distribution
2 states
ModerateFDA (Devices)··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, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080230. Laparoscopic Manual Instruments 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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Kelly Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 Kelly Forceps units because the instructions for use do not support specific sterilization methods.
Product
PKG, KELLY FORCEPS, CURVED LEFT, P/N 0250080283. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports whic
Category
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Bipolar Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of bipolar forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, BIPOLAR FORCEPS, FENESTRATED, 45CM, P/N 0250080350. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) por
Category
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Laparoscopic Obturator Packages Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of 11mm Obturator packages because the instructions for use do not support specific sterilization methods.
Product
PKG, OBTURATOR, 11MM, FOR HASSON CANNULA, P/N 0250080158. Laparoscopic Manual Instruments 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 Endoscopy Recalls 33cm Dorsey Grasper Forceps Due to Sterilization Labeling
Stryker Endoscopy is recalling 180,573 units of 33cm Dorsey Grasper Forceps because the instructions for use do not support specific sterilization methods.
Product
33CM DORSEY GRASPER FORCEPS, P/N 0250080319. Laparoscopic Manual Instruments 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 Dorsey Grasper Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling Dorsey Grasper Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM, 45CM, INSERT, DORSEY GRASPER FORCEPS, P/N 0250080736 Laparoscopic Manual Instruments 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
Distribution
2 states
LowFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Laparoscopic Graspers Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of laparoscopic atraumatic graspers because the provided instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, ATRAUMATIC GRASPER, SINGLE ACTION, 29CM, P/N 0250282099 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio fr
Category
Distribution
2 states
ModerateFDA (Devices)··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
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 laparoscopic manual instruments because the provided instructions for use do not support specific sterilization methods.
Product
PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (
Category
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Laparoscopic Micro Scissors Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of laparoscopic micro scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080029. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which
Category
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Laparoscopic Manual 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, 5MM PEEK HANDLE, 45CM, P/N 0250181164 Laparoscopic Manual Instruments 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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Pennington Forceps Recalled Due to Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 Pennington Forceps units because the instructions for use do not support specific sterilization methods.
Product
PKG, PENNINGTON FORCEPS, P/N 0250080242. Laparoscopic Manual Instruments 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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··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 0250080287. Laparoscopic Manual Instruments 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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls 180,573 Laparoscopic Graspers Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 laparoscopic atraumatic graspers because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, ATRAUMATIC GRASPER, DOUBLE ACTION, 20CM, P/N 0250282100 Laparoscopic Manual Instruments 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
Distribution
2 states
LowFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Laparoscopic Forceps Recalled Due to Sterilization Instructions Error
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, 29CM, P/N 0250282057 Laparoscopic Manual Instruments 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 Knot Pushers Recalled for Sterilization Labeling Errors
Stryker Endoscopy is recalling 180,573 laparoscopic knot pushers because the instructions for use do not support specific sterilization methods.
Product
PKG, KNOT PUSHER 5MM OPEN, P/N 0250080132 Laparoscopic Manual Instruments 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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Laparoscopic Dissector Recalled for Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 laparoscopic dissectors because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM X 33CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250080757 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio fre
Category
Distribution
2 states
LowFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Laparoscopic Forceps Recalled Due to Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 units of bipolar forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080360. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) por
Category
Distribution
2 states