Disposable Bipolar Forceps Recalled for Incorrect Expiration Date Labeling
Stryker Corporation is recalling certain Spetzler-Malis Bipolar forceps due to incorrect expiration dates on product labels. The labels indicate a 54-month shelf life, but 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 involving a labeling error where the product shelf life is overstated by 18 months with no reported incidents of patient harm. The mislabeled expiration date represents a risk-of-harm product where injury has not yet been reported, meeting the criteria for a High severity classification.
Plain-English summary
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps (Catalog Number 6770-230-010) due to an error in the product label's expiration date. The labels incorrectly state a 54-month (4.5-year) shelf life when the actual shelf life is 36 months (3 years).
The affected lot numbers are 200507015, 200515010, and 201008014. These surgical devices have been distributed in the United States nationwide and internationally in Australia, Canada, Japan, Korea, and Singapore.
The expiration date on a medical device label is critical for determining product safety and efficacy. Using a device beyond its intended shelf life could result in loss of sterility, device degradation, or malfunction during surgical use.
Healthcare facilities and surgical centers should identify products with the affected lot numbers and remove them from active inventory. These units should not be used and should be managed according to medical device disposal guidelines.
The recalled product
- Product
- Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-230-010
- Manufacturer
- Stryker Corporation
- Hazard
- labeling-error
- incorrect-expiration-date
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: 7613327300222
- Lot Numbers: 200507015
- 200515010
- 201008014
Distribution
Distributed nationwide across the United States.
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