Stryker Disposable Bipolar Forceps Recalled for Overstated Shelf Life
Stryker Corporation recalls 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to incorrect expiration dates on product labels. The actual shelf life is 36 months, but labels indicate 54 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 a labeling error that overstates the shelf life of a surgical instrument. Although no illnesses or injuries have been reported, the mislabeled expiration date (54 months vs. actual 36 months) creates a risk of harm if devices are used beyond their actual usable life during surgical procedures.
Plain-English summary
Stryker Corporation is recalling Disposable Spetzler-Malis Bipolar forceps (Catalog Number 6760-230-015, 23cm with bayonet 1.5mm tip) due to an error in the expiration date listed on product labels. The actual shelf life of the product is 36 months, but the labels indicate a shelf life of 54 months.
This discrepancy means that devices used beyond their actual 36-month shelf life could be compromised, potentially affecting their performance during surgical procedures. The affected lot is 200507009, and 2,321 total units have been distributed.
The recall affects supplies distributed in the United States nationwide, as well as Australia, Canada, Japan, Korea, and Singapore. Customers who have these forceps in stock should check the product lot number and verify the actual expiration date rather than relying on the label information.
Healthcare providers should take immediate steps to identify and segregate affected units to prevent accidental use beyond the 36-month shelf life.
The recalled product
- Product
- Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015
- Manufacturer
- Stryker Corporation
- Affected units
- 2,321
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: 7613327300246
- Lot Numbers: 200507009
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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