Steris Corporation: Medical Device Recall in 2022 - (Recall #: Z-0079-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 2, 2022

Date Posted: October 19, 2022

Recall Number: Z-0079-2023

Event ID: 90837

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.

Status: Terminated

Product Quantity: 5 US; 62 OUS

Code Information:

UDI-DI (GTIN): 10889950014193 Lots 0322, 0521, 0522, and 0621

Distribution Pattern:

Distribution to US states of IL, MA, NC, SC, and TN, Canada, China, Japan, Malaysia, Turkey, Great Britain, and India.

Voluntary or Mandated:

Voluntary: Firm initiated