Medical Action Industries Littauer Scissors Recalled for Debris Contamination
Medical Action Industries is recalling Littauer surgical scissors because the sterile instruments may contain debris that could compromise their safety during clinical use.
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 an FDA Class II recall for contamination of sterile surgical instruments with debris. Although no injuries have been reported, the presence of debris in instruments used in sterile surgical procedures represents a direct risk of harm through potential infection or other complications.
Plain-English summary
Medical Action Industries Inc. is recalling 145 cases of sterile Littauer Scissors (REF 56247) due to debris found in the instruments. The recalled product was distributed to healthcare facilities in Florida, Illinois, Indiana, Massachusetts, Maryland, Missouri, Ohio, and Virginia.
The scissors are designed for use in sterile surgical environments. Debris in sterile instruments could compromise sterility and potentially increase the risk of complications during clinical use.
Healthcare providers that received lot #297668 (UDI 10809160003473) should immediately remove this product from service. Affected facilities should contact Medical Action Industries Inc. for replacement or return instructions.
The recalled product
- Product
- Medical Action Industries Inc. Disposable Instrument Pack, Littauer Scissor, REF 56247, packaged 1/package, 20 packages/box, 12 boxes/case, sterile.
- Manufacturer
- Medical Action Industries, Inc. 306
- Hazard
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 (2)
- Lot #297668
- UDI 10809160003473.
Distribution
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