The Recall Desk
ModerateFDA (Devices)·Z-0248-2024·Announced 2023-11-15

Disposable Bipolar Forceps Shelf Life Labeling Error Stryker

Stryker recalls disposable Spetzler-Malis bipolar forceps due to incorrect shelf life labeling. The label states 54 months but 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 recall is classified as Moderate because the issue is a labeling error regarding shelf life expiration dating, which matches the Score 2 criterion for 'minor labeling errors.' No illnesses or injuries have been reported.

Plain-English summary

Stryker Corporation is recalling disposable Spetzler-Malis bipolar forceps (catalog number 6770-200-005, 20cm with bayonet tip) due to a labeling error. The issue affects 2,321 units with lot numbers 200924012, 201001029, 201022005, and 201029006.

The product label incorrectly states a shelf life of 54 months (4.5 years), when the actual safe shelf life is 36 months (3 years). This error could result in devices being used beyond their intended expiration date, potentially compromising their performance.

The affected units were distributed to facilities in the United States, Australia, Canada, Japan, Korea, and Singapore. Healthcare providers should identify affected lots in their inventory and ensure that the correct 36-month shelf life is used to determine device expiration dates.

The recalled product

Product
Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005
Manufacturer
Stryker Corporation
Hazard
  • labeling-error

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: 7613327300185
  • Lot Numbers: 200924012
  • 201001029
  • 201022005
  • 201029006

Distribution

Distributed nationwide across the United States.