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

1–25 of 207

LowFDA (Devices)··2014-12-24
Stryker Fundus Grasper Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling Fundus Grasper Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM, 45CM, INSERT, FUNDUS GRASPER FORCEPS, P/N 0250080735 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (R
Category
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Laparoscopic Grasper Recall Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic blunt graspers because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, BLUNT GRASPER, 29CM, P/N 0250282056 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
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, RING HANDLE, P/N 0250080236. 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 to
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, 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
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, 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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Allis Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 Allis Forceps units because the instructions for use do not support specific sterilization methods.
Product
PKG, ALLIS FORCEPS, P/N 0250080240. 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
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 th
Category
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Laparoscopic Scissors Recalled for Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 units of 3mm Hook Scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, HOOK SCISSORS, 20CM, P/N 0250282002 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
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Laparoscopic Needle Nose Forceps Recalled for Sterilization Instructions
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, NEEDLE NOSE FORCEPS, P/N 0250080048. 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 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
Distribution
2 states
ModerateFDA (Devices)··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, SPRING HANDLE, P/N 0250080237. 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
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, PORTIO ACORN SMALL ONLY, P/N 0250080139; 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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Laparoscopic Scissors Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 units of Endo Metzenbaum Scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250080267. 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 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
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
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls 3mm PEEK Monopolar Handle Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 units of 3mm PEEK Monopolar Handles because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM PEEK MONOPOLAR HANDLE, P/N 0250282045 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
LowFDA (Devices)··2014-12-24
Stryker Laparoscopic Forceps Recalled for Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 units of OP-VIOPSY Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports wh
Category
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Biopsy Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling biopsy forceps 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
Distribution
2 states
ModerateFDA (Devices)··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
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 instructions for use do not support specific sterilization methods.
Product
PKG, ASPIRATION NEEDLE, 33CM, P/N 0250080702 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 Mixter Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 Mixter Forceps units because the instructions for use do not support specific sterilization methods.
Product
PKG, MIXTER FORCEPS, P/N 0250080285. 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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Laparoscopic Dissecting Forceps Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 units of laparoscopic dissecting forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM X 33CM INSERT, DISSECTING FORCEPS, P/N 0250080760 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 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
Distribution
2 states