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

51–75 of 207

ModerateFDA (Devices)··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
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)…
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 Babcock Grasper Forceps Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of Babcock Grasper Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, BABCOCK GRASPER FORCEPS, 45CM, P/N 0250080586 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency…
Category
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…
Category
Distribution
2 states
ModerateFDA (Devices)··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
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, 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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Blakesly Biopsy Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling Blakesly Biopsy Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, BLAKESLY BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080293. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Peritoneal Scissors Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of peritoneal scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, PKG, PERITONEAL SCISSORS, P/N 0250080262. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which…
Category
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 Bipolar Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of bipolar forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, BIPOLAR FORCEPS, FENESTRATED, 45CM, P/N 0250080350. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
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)…
Category
Distribution
2 states
LowFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Laparoscopic Instruments Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support two specific sterilization methods.
Product
PKG, 5MM MULTI-FUNCTION PEEK HANDLE, P/N 0250181106 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
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 0250080113. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Laparoscopic Needle Holder Recall Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic needle holders because the instructions for use do not support specific sterilization methods.
Product
PKG, NEEDLE HOLDER, CURVED LEFT, P/N 0250080341. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Biopsy Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of biopsy forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, BIOPSY FORCEPS, 29CM, P/N 0250282059 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Alligator Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of Alligator Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, ALLIGATOR FORCEPS, P/N 0250080316. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow…
Category
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
LowFDA (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, 5MM INSERT, HOOK SCISSORS, 45CM, P/N 0250080573 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
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 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, SCHERTEL FORCEPS, FENESTRATED, P/N 0250080312. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Distribution
2 states
ModerateFDA (Devices)··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
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
LowFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Laparoscopic Grasper Forceps Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of laparoscopic grasper forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, GRASPER FORCEPS, SERRSTED FENESTRATED, P/N 0250080318. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF)…
Category
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls 10mm Clip Applying Forceps Due to Sterilization Documentation
Stryker Endoscopy is recalling 180,573 units of 10mm Clip Applying Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 10MM CLIP APPLYING FORCEPS, P/N 0250080558. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Fundus Grasper Instruments Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 Fundus Grasper instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, FUNDUS GRASPER, 29CM, P/N 0250282050 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports…
Category
Distribution
2 states