Scalpel Handle Recall: Hu-Friedy K360 Separates and Poses Choking Risk
Hu-Friedy K360 scalpel handles may separate from the grip during use, allowing the tip to fall into a patient's mouth and cause cuts or choking.
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: FDA Class II recall involving risk of harm (choking, laceration) if the defect occurs during use. Per the rubric, risk-of-harm products where injury has not yet been reported score at most 3. No illnesses or injuries have been reported.
Plain-English summary
The Hu-Friedy K360 Scalpel Handle, manufactured by Steris Corporation, is being recalled because the scalpel holder may separate from the handle during use.
If the tip separates and falls into a patient's mouth during a procedure, it could cause cuts to the mouth tissue and presents a choking hazard. No injuries have been reported to date.
The recall affects 5 units distributed within the United States to healthcare facilities in Illinois, Massachusetts, North Carolina, South Carolina, and Tennessee, and 62 units distributed internationally to Canada, China, Japan, Malaysia, Turkey, Great Britain, and India. The affected lots are 0322, 0521, 0522, and 0621.
The recalled product
- Product
- Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
- Manufacturer
- Steris Corporation
- 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 (4)
- UDI-DI (GTIN): 10889950014193 Lots 0322
- 0521
- 0522
- and 0621
Distribution
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