Hu-Friedy K360 Scalpel Handle — Class II medical device recall Z-0079-2023
Terminated recall by Steris Corporation, reported 2022-10-19, distributed in IL, MA, NC, SC, TN. The scalpel holder may separate from the handle for certain lots. If the tip falls off during use, it could fa
| Recall number | Z-0079-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Steris Corporation, Mentor, OH, United States |
| Recall initiated | 2022-09-02 |
| Classified | 2022-10-12 |
| Reported by FDA | 2022-10-19 |
| Terminated | 2025-01-02 |
| Distributed | IL, MA, NC, SC, TN |
| Countries outside the US | CA, CN, GB, IN, JP, MY, TR |
| UPC / GTIN / UDI-DI | 10889950014193 |
| Lot numbers | 0322, 0521, 0522, 0621 |
| Model numbers | K360 |
Product
Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0079-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.