Disposable Spetzler-Malis Bipolar Forceps recalled for expiration date labeling discrepancy
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar Forceps because the product label incorrectly shows 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 is an FDA Class II recall for a surgical instrument with a labeling error that overstates shelf life by 18 months. While no illnesses or injuries have been reported, the error poses a risk of harm if the forceps are used beyond their validated shelf life, which could compromise sterility assurance and device integrity during surgical use.
Plain-English summary
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar Forceps, 20CM SLM DISP BAYONET 0.5MM (Catalog Number 6780-200-005). The recall addresses an expiration date labeling error identified on the product packaging.
The product label indicates a shelf life of 54 months (4.5 years), however the actual validated shelf life for these products is 36 months (3 years). This discrepancy could result in use of the forceps beyond their intended expiration date, potentially compromising sterility assurance and product integrity for surgical applications.
The affected lots include: 201008016, 201015014, 201029008, and 201210016. These products were distributed nationwide in the United States, as well as to Australia, Canada, Japan, Korea, and Singapore.
Consumers and healthcare facilities with these products should verify the actual expiration date based on the correct 36-month shelf life and discontinue use if the product has reached the true expiration date. Contact Stryker Corporation for further guidance or replacement of affected units.
The recalled product
- Product
- Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-200-005
- Manufacturer
- Stryker Corporation
- Hazard
- labeling-error
- shelf-life-discrepancy
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: 7613327300277
- Lot Numbers: 201008016
- 201015014
- 201029008
- 201210016
Distribution
Distributed nationwide across the United States.
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