Stryker Surgical Forceps Recalled for Incorrect Expiration Date Label
Stryker Corporation is recalling 2,321 units of disposable surgical forceps due to a labeling error. The label indicates a 54-month shelf life, but the products actually expire in 36 months.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a Class II recall involving incorrect expiration dating on a surgical instrument. While no injuries have been reported, the mislabeled shelf life creates a risk of using expired medical devices, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps (Catalog Number 6760-180-015) distributed in the United States and internationally, including Australia, Canada, Japan, Korea, and Singapore. The affected lot numbers are 201119005 and 201210009.
The recall was initiated due to a labeling error. The shelf life for these products is 36 months (3 years); however, the product label incorrectly represents a shelf life of 54 months (4.5 years). This labeling discrepancy could result in the use of expired surgical instruments.
Healthcare providers and users should verify the actual manufacturing dates against the correct 36-month shelf life rather than relying on the package label. Facilities using these forceps with the identified lot numbers should quarantine the affected units and contact Stryker Corporation for instructions on replacement or return.
The recalled product
- Product
- Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-180-015
- 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 (3)
- GTIN: 7613327300376
- Lot Numbers: 201119005
- 201210009
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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