The Recall Desk
HighFDA (Devices)·Z-0240-2024·Announced 2023-11-15

Stryker Surgical Forceps Recalled for Incorrect Expiration Date Label

Stryker Corporation is recalling 2,321 units of disposable surgical forceps due to a labeling error. The label indicates a 54-month shelf life, but the products actually expire in 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 recall involving incorrect expiration dating on a surgical instrument. While no injuries have been reported, the mislabeled shelf life creates a risk of using expired medical devices, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps (Catalog Number 6760-180-015) distributed in the United States and internationally, including Australia, Canada, Japan, Korea, and Singapore. The affected lot numbers are 201119005 and 201210009.

The recall was initiated due to a labeling error. The shelf life for these products is 36 months (3 years); however, the product label incorrectly represents a shelf life of 54 months (4.5 years). This labeling discrepancy could result in the use of expired surgical instruments.

Healthcare providers and users should verify the actual manufacturing dates against the correct 36-month shelf life rather than relying on the package label. Facilities using these forceps with the identified lot numbers should quarantine the affected units and contact Stryker Corporation for instructions on replacement or return.

The recalled product

Product
Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-180-015
Manufacturer
Stryker Corporation
Hazard
  • mis-labeling
  • expired-device-risk

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 (3)

  • GTIN: 7613327300376
  • Lot Numbers: 201119005
  • 201210009

Distribution

Distributed nationwide across the United States.