Z-0079-2023 Class II Terminated
FDA device recall Z-0079-2023 was initiated by Steris Corporation on Sep 2, 2022 and is designated Class II. 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… The recall status is terminated (terminated Jan 2, 2025). Affected quantity: 5 US; 62 OUS.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 19, 2022
- Initiation Date
- Sep 2, 2022
- Termination Date
- Jan 2, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 US; 62 OUS
Product Description
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.
Distribution Pattern
Distribution to US states of IL, MA, NC, SC, and TN, Canada, China, Japan, Malaysia, Turkey, Great Britain, and India.
Code Information
UDI-DI (GTIN): 10889950014193 Lots 0322, 0521, 0522, and 0621
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0079-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026