The Recall Desk
ModerateFDA (Devices)·Z-0606-2015·Announced 2014-12-24

Stryker Maryland Forceps Recalled Due to Sterilization Instructions

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 does not report any hospitalizations or injuries. The hazard is a documentation issue regarding sterilization methods, which fits the criteria for a moderate severity recall involving labeling or documentation errors.

Plain-English summary

Stryker Endoscopy is recalling 180,573 units of Maryland Forceps, Curved (P/N 0250080009). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and surgical auxiliaries. The recall is due to a defect in the Instructions for Use (IFU 1000-401-070 Revision G or prior), which 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. The source text does not report any illnesses or injuries associated with this recall.

Healthcare facilities should stop using the affected instruments and contact Stryker Endoscopy for instructions on how to proceed. Consumers are not expected to have these surgical instruments in their homes.

The recalled product

Product
PKG, MARYLAND FORCEPS, CURVED, P/N 0250080009. 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
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)

  • 06CON06090 06CON06322

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 →