Stryker Bipolar Forceps Recalled for Incorrect Expiration Date Label
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to incorrect expiration date labeling. The label states a 54-month shelf life when 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 2/5 (Moderate).
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: FDA Class II device with a labeling error and no reported illnesses or injuries. The incorrect expiration date on the label poses a theoretical risk if devices are used past their actual shelf life, but this is a compliance and labeling issue rather than a defect in the device itself.
Plain-English summary
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps (Catalog Number 6780-230-015, 23CM SLM DISP BAYONET 1.5MM) due to an error on the product label. The label indicates a shelf life of 54 months (4.5 years), but the actual shelf life is 36 months (3 years). Affected Lot Numbers are 200423023, 200525015, 200806014, and 201015018.
The labeling error means these surgical instruments may be used beyond their actual expiration date, potentially compromising sterility and functionality. These devices were distributed nationwide in the United States and internationally to Australia, Canada, Japan, Korea, and Singapore.
Healthcare facilities and medical professionals should identify any units of this product nearing or past their 36-month actual expiration date and should not use devices beyond the correct expiration date. Contact Stryker Corporation for instructions regarding affected units.
The recalled product
- Product
- Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015
- 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 (5)
- GTIN: 7613327300239
- Lot Numbers: 200423023
- 200525015
- 200806014
- 201015018
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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