The Recall Desk
ModerateFDA (Devices)·Z-0242-2024·Announced 2023-11-15

Disposable Surgical Forceps Recalled for Incorrect Expiration Date Labeling

Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to an error in the product label's expiration date. The label indicates a 54-month shelf life when the actual shelf life is 36 months.

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: This is a minor labeling error affecting expiration dating without reported injuries or illnesses. FDA Class II classification with no hospitalization reports. The hazard is theoretical, contingent on use beyond the actual 36-month shelf life.

Plain-English summary

Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps (Catalog Number 6760-230-005) due to a labeling error affecting the product's expiration date. The product label indicates a shelf life of 54 months (4.5 years), but the actual shelf life is 36 months (3 years). Lot Numbers 200507007, 200515006, and 201203014 are affected.

The recalled devices have been distributed throughout the United States and internationally to Australia, Canada, Japan, Korea, and Singapore. Using a surgical instrument beyond its actual expiration date may result in device degradation or failure, potentially affecting surgical performance and patient safety.

Healthcare providers and users of the affected lot numbers should immediately discontinue use of these devices. Contact Stryker Corporation with the product's lot number and catalog number for replacement or return instructions.

The recalled product

Product
Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-230-005
Manufacturer
Stryker Corporation
Hazard
  • labeling-error
  • shelf-life-mismatch

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 (4)

  • GTIN: 7613327300253
  • Lot Numbers: 200507007
  • 200515006
  • 201203014

Distribution

Distributed nationwide across the United States.