Hu-Friedy K360 Scalpel Handle recall
Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
Why was Hu-Friedy K360 Scalpel Handle recalled?
The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fall into the patient's mouth which may result in a cut to the patient's mouth and also presents a choking hazard.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI (GTIN): 10889950014193 Lots 0322, 0521, 0522, and 0621
- Product
- Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
- Recalling firm
- Steris Corporation
- Quantity
- 5 US; 62 OUS
- Distribution
- Distribution to US states of IL, MA, NC, SC, and TN, Canada, China, Japan, Malaysia, Turkey, Great Britain, and India.
- Recall date
- October 19, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)