The Recall Desk
ModerateFDA (Devices)·Z-0256-2024·Announced 2023-11-15

Stryker surgical forceps recall due to incorrect expiration date labeling

Stryker Corporation is recalling Spetzler-Malis Bipolar forceps due to incorrect shelf-life labeling. The devices are labeled with a 54-month shelf life but actually expire after 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 labeling error affecting a Class II medical device with no reported injuries or illnesses. The hazard is theoretical—potential use of expired instruments—without documented adverse events, fitting the 'Moderate' category for minor labeling errors.

Plain-English summary

Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps (Catalog Number 6780-230-010). The recall is due to an error in the expiration date labeling on the product.

The product label indicates a shelf life of 54 months (4.5 years), but the actual shelf life is only 36 months (3 years). This discrepancy means that products may expire sooner than indicated on the label.

Affected devices were distributed in the United States, as well as to Australia, Canada, Japan, Korea, and Singapore. The recalled lot numbers are 200525014, 201015017, and 201112017.

Because of the labeling error, there is a risk that devices could be used beyond their actual 36-month shelf life. Healthcare providers and facilities using these devices should verify the actual product shelf life.

The recalled product

Product
Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-230-010
Manufacturer
Stryker Corporation
Hazard
  • labeling-error
  • shelf-life-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 (4)

  • GTIN: 7613327300178
  • Lot Numbers: 200525014
  • 201015017
  • 201112017

Distribution

Distributed nationwide across the United States.