Stryker disposable surgical forceps recalled for incorrect expiration date labeling
Stryker Corporation is recalling 2,321 Spetzler-Malis bipolar surgical forceps due to incorrect expiration date labeling. The product label states a 54-month shelf life when the actual shelf life is only 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 medical device recall involving labeling errors on a surgical instrument. Although no illnesses or injuries have been reported, the mislabeled expiration dates create a risk-of-harm scenario where expired surgical devices could be used in invasive patient procedures.
Plain-English summary
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps (Catalog Number 6760-230-010, Lot Number 200507008) due to an expiration date labeling error. The product label states a shelf life of 54 months (4.5 years), but the actual shelf life is 36 months (3 years).
This discrepancy creates a risk that surgical professionals could use expired instruments in patient procedures. Medical device sterility and integrity degrade over time, and using an expired surgical instrument during an invasive procedure could compromise patient safety.
The affected products were distributed nationwide in the United States as well as in Australia, Canada, Japan, Korea, and Singapore. Healthcare facilities and surgical centers should verify the correct shelf life of their inventory against product labels and remove any expired units from use.
Patients and healthcare providers should contact Stryker Corporation with questions about the affected products. No injuries or adverse events have been reported in connection with this labeling error.
The recalled product
- Product
- Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-010
- Manufacturer
- Stryker Corporation
- Hazard
- mis-labeling
- expired-device-risk
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 (2)
- GTIN: 7613327300291
- Lot Numbers: 200507008
Distribution
Distributed nationwide across the United States.
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