# FDA recall Z-0079-2023

> **Steris Corporation** · Class II · device recall initiated 2022-09-02.

## 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

- **Recall number:** Z-0079-2023
- **Recalling firm:** Steris Corporation
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0079-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0079-2023. Source: US FDA. Licensed CC0.

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