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.
“Hu-Friedy K360 Scalpel Handle Recall: Tip May Fall Off During Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60094-hu-friedy-k360-scalpel-handle-recall-tip-may-fall-off. Based on FDA recall #Z-0079-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0079-2023%22&limit=1).
The FDA announced on Sept. 2, 2022, that Steris Corporation is recalling Hu-Friedy K360 Scalpel Handles due to a hazard where the scalpel holder may separate from the handle. This defect could cause the tip to fall into a patient's mouth, resulting in cuts or choking.
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, according to the FDA.
Context
GovInfoNow's records show Steris Corporation has 29 other recalls on record since June 15, 2017. Other recent recalls of similar products include Merit Medical Custom Procedure Kit Recall (Dec. 4, 2025), Merit Medical Vascular Tray Recall (Dec. 4, 2025), and Merit Medical Custom Manifold Kit Recall (Dec. 4, 2025).
How to tell if you have this one
Check for the lot numbers 0322, 0521, 0522, or 0621 on the product's UDI-DI (GTIN) label. The product is a 360-degree scalpel handle with reference number K360.
Brand
Hu-Friedy
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Lot Number
Look for lot numbers 0322, 0521, 0522, or 0621 on the UDI-DI (GTIN) label.
Where it went and when
Where it was distributed
Distributed in 5 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Distribution to US states of IL, MA, NC, SC, and TN, Canada, China, Japan, Malaysia, Turkey, Great Britain, and India.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Illinois, Massachusetts, North Carolina, South Carolina, Tennessee.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0079-2023 (September 2, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0079-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.