The Recall Desk
HighFDA (Devices)·Z-0246-2024·Announced 2023-11-15

Stryker Bipolar Surgical Forceps Recalled for Incorrect Expiration Label

Stryker Corporation is recalling 2,321 units of disposable bipolar surgical forceps with incorrect expiration dates on their labels. The devices are labeled with 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 FDA Class II labeling error represents a risk-of-harm product—a surgical instrument potentially used beyond its intended shelf life—without reported illness or injury, fitting the Score 3 (High) severity criterion.

Plain-English summary

Stryker Corporation is recalling 2,321 units of disposable Spetzler-Malis bipolar surgical forceps due to an error in the product label. The label indicates a shelf life of 54 months (4.5 years) when the actual shelf life is 36 months (3 years).

The recalled product is the 18CM IM DISP BAYONET 1.0MM TIP model, catalog number 6770-180-010. Affected lot numbers are 200515007, 200731007, 200924011, and 201001028. The devices were distributed nationwide in the United States and internationally in Australia, Canada, Japan, Korea, and Singapore.

The discrepancy between the labeled and actual shelf life means devices may be used beyond their intended shelf life if users rely on the label. Customers should be aware of the difference when managing inventory and using these products.

The recalled product

Product
Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-180-010
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: 7613327300260
  • Lot Numbers: 200515007
  • 200731007
  • 200924011
  • 201001028

Distribution

Distributed nationwide across the United States.