The Recall Desk
ModerateFDA (Devices)·Z-0620-2015·Announced 2014-12-24

Stryker Maryland Forceps Recalled Due to Sterilization Parameter Errors

Stryker Endoscopy is recalling Maryland Forceps 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 identifies the issue as a documentation error regarding sterilization parameters without reporting any illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Stryker Endoscopy is recalling 180,573 units of Maryland Forceps, Curved, Left (P/N 0250080042). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgery. The devices are distributed worldwide, including in the United States and numerous international locations.

The recall is issued 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 error may affect the proper sterilization of the instruments.

Healthcare facilities and users should stop using the affected instruments and contact Stryker Endoscopy for further instructions on how to proceed.

The recalled product

Product
PKG, MARYLAND FORCEPS, CURVED, LEFT, P/N 0250080042. 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
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)

  • 06CON01282 06CON06099 06CON06100 06CON08779 06CON08780

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 →