Stryker surgical forceps recall due to incorrect expiration date labeling
Stryker Corporation is recalling Spetzler-Malis Bipolar forceps due to incorrect shelf-life labeling. The devices are labeled with a 54-month shelf life but actually expire after 36 months.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a labeling error affecting a Class II medical device with no reported injuries or illnesses. The hazard is theoretical—potential use of expired instruments—without documented adverse events, fitting the 'Moderate' category for minor labeling errors.
Plain-English summary
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps (Catalog Number 6780-230-010). The recall is due to an error in the expiration date labeling on the product.
The product label indicates a shelf life of 54 months (4.5 years), but the actual shelf life is only 36 months (3 years). This discrepancy means that products may expire sooner than indicated on the label.
Affected devices were distributed in the United States, as well as to Australia, Canada, Japan, Korea, and Singapore. The recalled lot numbers are 200525014, 201015017, and 201112017.
Because of the labeling error, there is a risk that devices could be used beyond their actual 36-month shelf life. Healthcare providers and facilities using these devices should verify the actual product shelf life.
The recalled product
- Product
- Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-230-010
- 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 (4)
- GTIN: 7613327300178
- Lot Numbers: 200525014
- 201015017
- 201112017
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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