The Recall Desk
ModerateFDA (Devices)·Z-0250-2024·Announced 2023-11-15

Disposable Bipolar Forceps Recalled for Incorrect Expiration Date Labeling

Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to incorrect expiration date labeling. The product label indicates a 54-month shelf life, but 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 recall involves a labeling error on FDA Class II medical devices. The product label incorrectly states a 54-month shelf life instead of the actual 36-month shelf life. No injuries or illnesses have been reported.

Plain-English summary

Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps, Catalog Number 6770-230-005, due to an error in the expiration date labeling. The product label indicates a shelf life of 54 months (4.5 years), but the actual shelf life of the product is 36 months (3 years).

The affected lot numbers are 200515009, 201008013, 201015011, and 201126013. The products were distributed in the United States as well as internationally to Australia, Canada, Japan, Korea, and Singapore.

Users of these surgical forceps should verify the actual expiration date (36 months from manufacture) and not rely on the label indication of 54 months. Contact Stryker Corporation for verification of actual expiration dates for units in question. Facilities should conduct an inventory review of any affected lots in their possession.

The recalled product

Product
Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-230-005
Manufacturer
Stryker Corporation
Hazard
  • expiration-date-mislabeling

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 (5)

  • GTIN: 7613327300161
  • Lot Numbers: 200515009
  • 201008013
  • 201015011
  • 201126013

Distribution

Distributed nationwide across the United States.