The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0712-2015·Announced 2014-12-24

Stryker Endoscopy Recalls Bowel Grasper Forceps Due to Sterilization Documentation Error

Stryker Endoscopy is recalling 180,573 units of Bowel Grasper Forceps because the instructions for use do not support specific sterilization methods.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, which typically corresponds to a Moderate severity score (2) when no hospitalizations or significant injuries are reported, fitting the criteria for minor labeling/documentation errors or low-risk contamination.

Plain-English summary

Stryker Endoscopy is recalling 180,573 units of PKG, 5MM INSERT, BOWEL GRASPER FORCEPS, 45CM, P/N 0250080587. These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgery. The recall is due to a documentation error 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 units were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Canada, Mexico, the United Kingdom, Germany, and Japan. The recall is classified as Class II by the FDA, indicating that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Endoscopy for further instructions regarding the return or replacement of the devices. No specific illnesses or injuries have been reported in the source text, but the documentation error may impact the proper sterilization of the instruments.

The recalled product

Product
PKG, 5MM INSERT, BOWEL GRASPER FORCEPS, 45CM, P/N 0250080587 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…
Manufacturer
Stryker Endoscopy
Category
Medical Device — Surgical Instruments
Hazard
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)

  • 443971 344197 345141 746676 940548 940549 1146538 1245021

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 →

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