The Recall Desk
LowFDA (Devices)·Z-0745-2015·Announced 2014-12-24

Stryker Laparoscopic Scissors Recalled Due to Sterilization Instructions Error

Stryker Endoscopy is recalling Metzenbaum curved 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 classified as FDA Class II, but the source text identifies the issue as a documentation error in the Instructions for Use regarding sterilization parameters. There are no reported injuries, illnesses, or deaths, and the hazard is theoretical, fitting the criteria for a Low severity score (documentation issues).

Plain-English summary

Stryker Endoscopy is recalling 180,573 units of Metzenbaum curved scissors, long jaw, P/N 0250080752. These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and surgical auxiliaries. The products were distributed nationwide in the United States and internationally to numerous countries.

The recall is due to an error in the Instructions for Use (IFU 1000-401-070 Revision G or prior). The parameters provided in these instructions do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods. This documentation issue may affect the proper sterilization of the devices.

Healthcare providers and facilities should stop using the affected instruments and contact Stryker Endoscopy for further instructions. The recall covers specific lot codes listed in the agency record.

The recalled product

Product
PKG, 5MM X 45CM, INSERT, METZENBAUM CURVED SCISSORS, LONG JAW, P/N 0250080752 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
Manufacturer
Stryker Endoscopy
Affected units
180,573

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 →