The Recall Desk
ModerateFDA (Devices)·Z-0702-2015·Announced 2014-12-24

Stryker Endoscopy Recalls Mini Metzenbaum Scissors Due to Sterilization Labeling Error

Stryker Endoscopy is recalling 180,573 units of Mini 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, but the source text explicitly states no illnesses or injuries are reported, and the hazard is a documentation/labeling issue regarding sterilization parameters rather than a direct physical defect causing harm.

Plain-English summary

Stryker Endoscopy is recalling 180,573 units of PKG, 5MM INSERT, MINI METZENBAUM SCISSORS, CURVED, 45CM (P/N 0250080574). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and surgical auxiliaries. The recall covers units distributed nationwide in the United States and internationally to numerous countries including Canada, the United Kingdom, Germany, and Japan.

The recall was initiated 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. This documentation discrepancy may affect the proper sterilization of the devices.

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

The recalled product

Product
PKG, 5MM INSERT, MINI METZENBAUM SCISSORS, CURVED, 45CM, P/N 0250080574 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 fre
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)

  • 841953 841956

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 →