The Recall Desk
LowFDA (Devices)·Z-0609-2015·Announced 2014-12-24

Stryker Laparoscopic Hook Scissors Recalled Due to Sterilization Instructions

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

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is driven by a documentation issue where the Instructions for Use do not support specific sterilization cycles, which aligns with the rubric for Low severity (documentation issues).

Plain-English summary

Stryker Endoscopy is recalling 180,573 units of PKG, HOOK SCISSORS, P/N 0250080020. These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue, organs, and surgical auxiliaries. The devices are designed to be used endoscopically through cannulae and do not sustain or support life.

The recall is issued because the parameters provided in the 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. This documentation issue affects the ability to verify proper sterilization for these specific cycles.

The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries. Users should stop using the affected instruments and contact Stryker Endoscopy for further instructions.

The recalled product

Product
PKG, HOOK SCISSORS, P/N 0250080020. 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
Manufacturer
Stryker Endoscopy
Affected units
180,573

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 06CON06092 AA3

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 207 recalled by Stryker Endoscopy under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 207 products in this recall →