HU-FRIEDY K360Recalls & reported problems
Hu-Friedy Mfg. CO., LLC · 360 Degree Scalpel Handle · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889950014193), received between Jul 13, 2022 and Jul 13, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Sep 2, 2022Terminated
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.
Z-0079-2023 · Root cause: Process design · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE WHICH INCLUDED USE OF A 360 DEGREE SCALPEL HANDLE, PART OF THE HANDLE DETACHED AND THE PATIENT OBTAINED A CUT.
Patient problems: Laceration(s)
MAUDE report 15008798 ↗
Other HANDLE, SCALPEL devices
- Centurion I68290Centurion Medical Products Corporation · HANDLE, SCALPEL1 recall0 reports
- Centurion 66825Centurion Medical Products Corporation · HANDLE, SCALPEL1 recall0 reports
- NA 03.010.491Synthes GmbH · HANDLE, SCALPEL23 reports
- NA 03.140.027Synthes GmbH · HANDLE, SCALPEL13 reports
- DeRoyal D4511ADeroyal Industries, Inc. · HANDLE, SCALPEL7 reports
- DeRoyal D4522NSDeroyal Industries, Inc. · HANDLE, SCALPEL1 report
- Integra® Jarit® 110175Integra Lifesciences Production Corporation · HANDLE, SCALPEL1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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