Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle… recallZ-0079-2023 · Steris Corporation · initiated Sep 2, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Steris Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process design
What the company is doing
Starting September 2, 2022, Hu-Friedy notified all affected customers and distributors via Urgent Medical Device Recall letters. Customers were instructed to immediately destroy all on-hand inventory of the affected lots of K360 Scalpel Handles. Distributors should identify and notify any of their customers who have received further distributed product. Hu-Friedy will issue credit upon receipt of completed response forms.
Recall details
- Recall number
- Z-0079-2023
- Status
- Terminated
- Initiated by the company
- Sep 2, 2022
- Posted by the FDA
- Oct 12, 2022
- Recalling firm
- Steris Corporation
- Quantity
- 5 US; 62 OUS
- Product code
- GDZ
- Distribution
- Distribution to US states of IL, MA, NC, SC, and TN, Canada, China, Japan, Malaysia, Turkey, Great Britain, and India.
Product description
Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
Code information (models, lots, serial numbers)
UDI-DI (GTIN): 10889950014193 Lots 0322, 0521, 0522, and 0621
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HU-FRIEDY K360Hu-Friedy Mfg. CO., LLC · HANDLE, SCALPEL1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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