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

101–125 of 207

ModerateFDA (Devices)··2014-12-24
Stryker Laparoscopic Manual Instruments 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 ROTATING HANDLE, INSULATED SHAFT/ HANDLE 45CM LENGTH, P/N 0250080595 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 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, MICRO TIP, 33CM, P/N 0250080362. 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 Laparoscopic Grasper Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic graspers because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, BLUNT WITH SPOON, GRASPER, 20CM, P/N 0250282008 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 Instruments Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 laparoscopic instruments because the provided instructions do not support specific sterilization methods.
Product
PKG, FUNDUS FORCEPS, P/N 0250080315. 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 Maryland Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling Maryland Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, MARYLAND FORCEPS, CURVED, P/N 0250080248. 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
HighFDA (Devices)··2014-12-24
Stryker Laparoscopic Scissors Recalled for Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 units of 3mm Peritoneal Scissors because the instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, PERITONEAL SCISSORS, 20CM, P/N 0250282001 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 Reducers Recalled for Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 laparoscopic reducers because the instructions for use do not support specific sterilization methods.
Product
PKG, 12.5/11MM - 5.5 REDUCER, P/N 0250080204. 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 Metzenbaum Scissors Recalled 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 0250080264. 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 5mm Right Angle Forceps Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of 5mm Right Angle Forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM INSERT, RIGHT ANGLE FORCEP, 45CM P/N 0250080729 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 Grasper Forceps Due to Sterilization Labeling
Stryker Endoscopy is recalling 180,573 units of atraumatic grasper forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, GRASPER FORCEPS, ATRAUMATIC, P/N 0250080323. 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 Babcock Forceps Due to Sterilization Instructions
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, PADDLE, P/N 0250080250. 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 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 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, SCHERTL GRASPER, FENESTRATED, 29CM, P/N 0250282053 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 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 FORCEP, BOWEL, P/N 0250080324. 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 allo
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 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 Needle Holder Recall Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 laparoscopic needle holders because the instructions for use do not support specific sterilization methods.
Product
PKG, 5MM SHAFT, NEEDLE HOLDER, STRAIGHT, 45CM, P/N 0250080588 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 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, STRIAGHT, P/N 0250080340. 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 Documentation Issues
Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the provided instructions for use do not support specific sterilization methods.
Product
PKG, 3MM INSERT, STRAIGHT NEEDLEHOLDER, 20CM, P/N 0250282014 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 PEEK Monopolar Handle Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 units of 10mm PEEK Monopolar Handles because the instructions for use do not support specific sterilization methods.
Product
PKG, 10MM PEEK MONOPOLAR HANDLE, P/N 0250080618 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 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, MICRO TIP, 45CM, P/N 0250080115 nationwide in US and worldwide: Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America
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, 5MM X 33CM, INSERT, FENESTRATED GRASPER, P/N 0250080755 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 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, ALLIS DOUBLE ROW TEETH, P/N 0250080592 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 allo
Category
Distribution
2 states
ModerateFDA (Devices)··2014-12-24
Stryker Endoscopy Recalls Laparoscopic Palpation Probes Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 laparoscopic palpation probes because the instructions for use do not support specific sterilization methods.
Product
PKG, PALPATION PROBE GRADUATED 5MM, P/N 0250080135; 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 for Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 laparoscopic forceps because the instructions for use do not support specific sterilization methods.
Product
PKG, BLUNT FORCEPS, BLUNT, SERRATED, SPOON, P/N 0250080313. 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