FDA Device recall Z-0079-2023
Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
- FDA Device
- Class II
- terminated
- Published 2022-10-19
On 2022-10-19 the FDA classified a Class II recall of Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360 by Steris, citing 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'….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0079-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-09-02 |
| Published | 2022-10-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Steris |
| Distribution | IL, MA, NC, SC, TN |
Product
Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
Reason
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.
Identifiers
| code_info | UDI-DI (GTIN): 10889950014193 Lots 0322, 0521, 0522, and 0621 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0079-2023%22
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