The Recall Desk

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 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

201–207 of 207

  • HighFDA (Devices)··2014-12-24

    Stryker Laparoscopic Scissors Recalled for Sterilization Parameter Errors

    Stryker Endoscopy is recalling 180,573 laparoscopic hook scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, HOOK SCISSORS, 29CM, P/N 0250282049 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 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, CURVED RIGHT, 45CM, P/N 0250080590 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 Aspiration Needles Due to Sterilization Documentation Error

    Stryker Endoscopy is recalling 180,573 aspiration needles because the instructions for use do not support specific sterilization methods.

    Product
    PKG, ASPIRATION NEEDLE, 45 CM, P/N 0250080703 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 Laparoscopic Instruments Recalled for Sterilization Documentation Issues

    Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 5MM INSERT, TENACULUM, 33CM, P/N 0250080698 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 180,573 Cobra Grasper Instruments Due to Sterilization Labeling

    Stryker Endoscopy is recalling 180,573 Cobra Grasper instruments because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, COBRA GRASPER, 20CM, P/N 0250282007 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
  • LowFDA (Devices)··2014-12-24

    Stryker Endoscopy Recalls Palpation Probes Due to Sterilization Instructions

    Stryker Endoscopy is recalling 180,573 palpation probes because the instructions for use do not support specific sterilization methods.

    Product
    PKG, PALPATION PROBE GRADUATED 5MM 45CM, P/N 0250080136 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 11mm Trocars Due to Sterilization Documentation Issues

    Stryker Endoscopy is recalling 180,573 units of 11mm trocars because the instructions for use do not support specific sterilization methods.

    Product
    PKG, TROCAR, 11MM, PYRAMIDAL TIP, P/N 0250080156. 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