Recall archive / FDA device enforcement
Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360 — FDA record Z-0079-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Sep 2, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Steris Corporation
- Quantity
- 5 US; 62 OUS
- Agency-reported status
- Terminated
- Source record identifier
- Z-0079-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI (GTIN): 10889950014193 Lots 0322, 0521, 0522, and 0621 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution to US states of IL, MA, NC, SC, and TN, Canada, China, Japan, Malaysia, Turkey, Great Britain, and India.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Oct 19, 2022
- Recall initiation date
- Sep 2, 2022
- Center classification date
- Oct 12, 2022
- Termination date
- Jan 2, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.