Z-0079-2023Class II

Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360

Name: Z-0079-2023 Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
Creator: Steris Corporation
Published: 2022-09-02
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2022-09-02 / Terminated / root cause: manufacturing process

FDA source

Steris Corporation began a recall of Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360 on 2022-09-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0079-2023
Classification: Class II
Status: Terminated
Initiated: 2022-09-02
Posted: 2022-10-12
Terminated: 2025-01-02
Recalling firm: STERIS Corporation
Product: Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360
Product code: GDZ Handle, Scalpel
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: 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.
Quantity in commerce: 5 US; 62 OUS
Distribution: Distribution to US states of IL, MA, NC, SC, and TN, Canada, China, Japan, Malaysia, Turkey, Great Britain, and India.
Product codes and lots: UDI-DI (GTIN): 10889950014193 Lots 0322, 0521, 0522, and 0621

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0079-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0079-2023	Class II	Terminated	Voluntary: Firm initiated	2022-10-19	2022-10-12

Product code GDZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)