DeRoyal D4522NSRecalls & reported problems
Deroyal Industries, Inc. · Safety Scalpel · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00749756811552), received between Aug 7, 2024 and Aug 7, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Retraction Problem” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Retraction Problem1
Patient problems
- Exposure to Body Fluids1
- 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.
InjuryAug 7, 2024Retraction Problem; Retraction Problem
WE HAVE RECEIVED A RATHER SERIOUS CUSTOMER COMPLAINT WHERE AN END-USER HAS CUT THEMSELVES ON A CONTAMINATED NO22 RETRACTABLE SCALPEL. THE SCALPEL HAS BEEN USED AND THEN THE BLADE HAS BEEN RETRACTED INTO THE PASSING POSITION. DUE TO THE TIGHTNESS OF THE TRIGGER, THE TIP OF THE BLADE HAS NOT BEEN FULLY RETRACTED IN THE SCALPEL AND THEY HAVE CUT THEMSELVES.
Patient problems: Exposure to Body Fluids; Laceration(s)
MAUDE report 19928475 ↗
Other HANDLE, SCALPEL devices
- HU-FRIEDY K360Hu-Friedy Mfg. CO., LLC · HANDLE, SCALPEL1 recall1 report
- Centurion 66825Centurion Medical Products Corporation · HANDLE, SCALPEL1 recall0 reports
- Centurion I68290Centurion 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
- Integra® Jarit® 110175Integra Lifesciences Production Corporation · HANDLE, SCALPEL1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.