FDA-Device2022-10-19Class II
Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
Hazard
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.
Sold states
Distribution to US states of IL, MA, NC, SC, and TN, Canada, China, Japan, Malaysia, Turkey, Great Britain, and India.
Affected count
5 US; 62 OUS
Manufactured in
5960 Heisley Rd, N/A, Mentor, OH, United States
Products
Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0079-2023More Steris Corporation recalls
- FDA-Device2026-06-24Steris HarmonyAIR A-Series Surgical Lighting System recalled for detachable control buttons
- FDA-Device2026-06-24Steris HarmonyAIR A-Series Surgical Lighting System recalled for paint delamination
- FDA-Device2026-06-24Steris ALYON Surgical Lighting System recalled for detachable control buttons
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