The Recall Desk
HighFDA (Devices)·Z-0241-2024·Announced 2023-11-15

Stryker Disposable Spetzler-Malis Bipolar Forceps Expiration Date Mislabeled

Stryker Corporation recalled disposable surgical forceps with mislabeled expiration dates. The product label incorrectly indicates a 54-month shelf life when the actual shelf life is 36 months.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall involving mislabeled expiration dating with potential risk of harm from using surgical instruments beyond their actual shelf life. No illnesses or injuries have been reported, and the hazard remains theoretical.

Plain-English summary

Stryker Corporation is recalling Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP (Catalog Number 6760-200-005), due to an expiration date labeling error. The product label states a shelf life of 54 months (4.5 years), but the actual shelf life is 36 months (3 years).

The recall affects 2,321 units distributed in the United States, Australia, Canada, Japan, Korea, and Singapore. Lot number 201105002 is involved.

The labeling error means surgical facilities using this lot number may unknowingly use devices beyond their actual approved shelf life. No illnesses or injuries have been reported.

The recalled product

Product
Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-200-005
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 (2)

  • GTIN: 7613327300284
  • Lot Numbers: 201105002

Distribution

Distributed nationwide across the United States.