The Recall Desk
ModerateFDA (Devices)·Z-0703-2015·Announced 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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a documentation/labeling error regarding sterilization methods. The source text does not report any illnesses or injuries, and the hazard is theoretical, fitting the criteria for a moderate severity score.

Plain-English summary

Stryker Endoscopy is recalling 180,573 units of PKG, 5MM INSERT, ENDO METZENBAUM SCISSORS, CURVED 45CM (P/N 0250080575). The recall is due to a documentation issue where 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 affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Canada, Mexico, Germany, and Japan. The recall is classified as Class II by the FDA.

Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Endoscopy for instructions on how to proceed. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

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
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 →