The Recall Desk
ModerateFDA (Devices)·Z-0253-2024·Announced 2023-11-15

Surgical forceps recalled due to mislabeled shelf life

Stryker Corporation is recalling Disposable Spetzler-Malis Bipolar forceps due to a labeling error showing an incorrect expiration date. The label states a 54-month shelf life when 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 is an FDA Class II medical device recall for a labeling error on shelf life. Labeling errors without reported harm are classified as Moderate severity per the rubric.

Plain-English summary

Stryker Corporation is recalling Disposable Spetzler-Malis Bipolar forceps (Catalog Number 6780-200-010) due to a labeling error on the product expiration date. The product label incorrectly represents a shelf life of 54 months (4.5 years), while the actual shelf life is 36 months (3 years).

The affected lot numbers are 200525011, 200806012, and 201015015. A total of 2,321 units have been distributed in the United States, Australia, Canada, Japan, Korea, and Singapore.

Customers who have received affected product should stop using it and contact Stryker Corporation for instructions. The mislabeled expiration date could result in use of products beyond their intended shelf life.

The recalled product

Product
Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-200-010
Manufacturer
Stryker Corporation
Hazard
  • labeling-error
  • shelf-life-mislabel

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: 7613327300369
  • Lot Numbers: 200525011
  • 200806012
  • 201015015

Distribution

Distributed nationwide across the United States.