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

151–175 of 207

ModerateFDA (Devices)··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
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 (R
Category
Distribution
2 states
ModerateFDA (Devices)··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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Schertel Forceps Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 units of Schertel Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, SCHERTEL FORCEPS, BLUNT FENESTRATED, P/N 0250080072. 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 Hasson Cannula Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 Hasson Cannula units because the instructions for use do not support specific sterilization methods.
Product
PKG, HASSON CANNULA, 5.5MM, AUTOMATIC VALVE, STOP COCK, P/N 0250080176. 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 Laparoscopic Manual Instruments Recalled for Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, LUERLOCK, MALE, 6MM TUBING, P/N 0250080207. 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 Endoloop Applicator Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 Endoloop Applicator units because the instructions for use do not support specific sterilization methods.
Product
PKG, ENDOLOOP APPLICATOR, P/N 0250080701 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 t
Category
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Babcock Forceps Due to Sterilization Documentation Errors
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, P/N 0250080321. 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 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
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls 5mm Metzenbaum Scissors Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of 5mm Metzenbaum Scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, ENDO METZENBAUM SCISSORS, CURVED 45CM, P/N 0250080575 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
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 wh
Category
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Peritoneal Scissors Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of 5mm x 45cm Peritoneal Scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM X 45CM, INSERT, PERITONEAL SCISSORS, P/N 0250080751 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 Fixation Clamp Recall Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic fixation clamps because the instructions for use do not support specific sterilization methods.
Product
PKG, FIXATION CLAMP 5MM WITH RATCHET, P/N 0250080130 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 Serrated Operating Scissors Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of Serrated Operating Scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, OPERATING SCISSORS, SERRATED, P/N 0250080247. 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 Scissors Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 units of Metzenbaum scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, METZENBAUM, CURVED, LONG SCISSORS, 29CM, P/N 0250282047 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 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, P/N 0250080292. 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 Metzenbaum Scissors 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 0250080024. 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 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, ASSY, 5MM PEEK MULTI HANDLE, 45CM, P/N 0250181108 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 Bullet Forceps Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of Bullet Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080041. 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 Laparoscopic Forceps Recalled Due to Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 units of laparoscopic forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, RIGHT ANGLE FORCEP, 33CM, P/N 0250080694 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
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, LUERLOCK, FEMALE, 6MM TUBING, P/N 0250080208. 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 180,573 Alligator Graspers Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of 3mm Alligator Graspers because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, ALLIGATOR GRASPER, 20CM, P/N 0250282004 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 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
ModerateFDA (Devices)··2014-12-24
Stryker Laparoscopic Grasper Recall Due to Sterilization Documentation Error
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, 20CM, P/N 0250282009 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 Maryland Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 Maryland Forceps instruments because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, MARYLAND, FORCEPS CURVED, 20CM, P/N 0250282011 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