Hu-Friedy K360 Scalpel Handle Recall: Tip May Fall Off During Use

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Recalling firmSteris Corporation5960 Heisley Rd, N/A · Mentor, OH 44060-1834

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Hu-Friedy is recalling certain K360 Scalpel Handles because they can separate from the handle during use, potentially causing cuts or choking if the tip falls into the patient's mouth.

Why it’s dangerous

The scalpel tip may detach from the handle for certain lots. If it falls during use, it could enter the patient's mouth, causing a cut or choking hazard.

Who’s affected

Healthcare professionals using the recalled scalpel handles in surgical settings are most at risk. Patients undergoing procedures with these handles could face injury if the tip separates.

How to tell if you have this one

Check for the lot numbers 0322, 0521, 0522, or 0621 on the product's UDI-DI (GTIN) label. The product is a 360-degree scalpel handle with reference number K360.

Brand
Hu-Friedy
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for lot numbers 0322, 0521, 0522, or 0621 on the UDI-DI (GTIN) label.

✎ GovInfoNow

Questions people ask

Why is this recall happening?

The scalpel holder may separate from the handle for certain lots, which could cause the tip to fall into the patient's mouth during use.

What should I do if I have this product?

Check the lot number on the product's UDI-DI (GTIN) label. If it matches 0322, 0521, 0522, or 0621, contact Hu-Friedy for instructions.

Is there a risk of serious injury?

Yes, if the tip falls into the patient's mouth during use, it could cause a cut or choking hazard.

Take action

Contact Hu-Friedy

We’ve drafted a message you can send Hu-Friedy to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0079-2023 — Hu-Friedy Hu-Friedy

Hello,

I own a Hu-Friedy that is covered by recall Z-0079-2023 from Hu-Friedy.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0079-2023 (September 2, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0079-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Steris Corporation recalls Hu-Friedy K360 Scalpel Handle, 360 Degree Scalpel Handle, REF K360

Use caution until it’s fixed