FDA recall Z-0079-2023

Product

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

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

Key facts

Status

Terminated

Initiation date

2022-09-02

Report date

2022-10-19

Termination date

2025-01-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Mentor, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0079-2023