Reported Oct 19, 2022 · Terminated

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

Steris Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Steris Corporation · 5960 Heisley Rd · Mentor, OH · 44060-1834

Is this the product you have?

    • Hu-Friedy K360 Scalpel Handle
    • 360 Degree Scalpel Handle
    • REF K360
Lot codes and dates
  • UDI-DI (GTIN)
    • 10889950014193 Lots 0322
    • 0521
    • 0522
    • and 0621
Amount recalled
5 US; 62 OUS

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 2, 2025 · Data as of Sep 19, 6:18 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.