CLASS II Device recall · Reported 19 Oct 2022 · FDA Enforcement Report

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

Steris is recalling Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, distributed in Illinois, Massachusetts, North Carolina, South Carolina, Tennessee. The recall was initiated on 2 Sep 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI (GTIN): 10889950014193 Lots 0322, 0521, 0522, and 0621

Quantity recalled5 US; 62 OUS

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0079-2023
FDA event ID: 90837
Recalling firm: Steris, Mentor, OH
Classification: Class II
Status: Terminated
Recall initiated: 2 Sep 2022
FDA classified: 12 Oct 2022
Reported: 19 Oct 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Choking Hazard
Device type: Surgical Instruments

Timeline

2 Sep 2022	Recall initiated by company
12 Oct 2022	Classified by FDA	+40 days
19 Oct 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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

Illinois Massachusetts North Carolina South Carolina Tennessee

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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