Stryker Disposable Bipolar Forceps Recalled for Expiration Date Labeling Error
Stryker Corporation is recalling 2,321 units of disposable bipolar forceps due to a labeling error. The product label shows a 54-month shelf life, but the actual shelf life is 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 medical device (surgical forceps) where the product label indicates a longer shelf life than the actual duration. Although no injuries have been reported, this is a risk-of-harm product where expiration-date mislabeling could result in use of expired surgical instruments.
Plain-English summary
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps (Catalog Number 6770-180-015) due to an expiration date labeling error. The product label indicates a shelf life of 54 months (4.5 years), but the actual shelf life is 36 months (3 years).
The affected lot numbers are 200515008, 200525009, 200626006, 200731008, and 200806007. These surgical instruments were distributed nationwide in the United States, as well as to Australia, Canada, Japan, Korea, and Singapore.
The mislabeled shelf life creates a discrepancy that could lead to use of the device beyond its actual expiration date. This recall was issued to address the labeling discrepancy and ensure that users are aware of the correct 36-month shelf life.
The recalled product
- Product
- Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-180-015
- Manufacturer
- Stryker Corporation
- Hazard
- 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 (6)
- GTIN: 7613327300321
- Lot Numbers: 200515008
- 200525009
- 200626006
- 200731008
- 200806007
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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