3-in-1 SHAVER™ 5.0mm R-10014Recalls & reported problems
Relign Corporation · Multi-functional shaver blade, disposable · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00859273007144), received between Jun 7, 2023 and Jan 19, 2024 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (3 reports).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Patient Device Interaction Problem3
- Flaked2
- Overheating of Device2
- Noise, Audible1
- Peeled/Delaminated1
Patient problems
- Burn(s)3
- No Clinical Signs, Symptoms or Conditions3
- Laceration(s)1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 19, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS REPORTED THAT METAL SHAVINGS COMING OFF THE 5.0 3-IN-1 SHAVER BLADES. THE EVENT OCCURRED DURING SURGERY. THERE WAS NO REPORTED PATIENT HARM, INCLUDING NO RETAINED FOREIGN BODIES, OR DELAY. DUE DILIGENCE IS COMPLETE, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18543260 ↗MalfunctionNov 30, 2023Flaked; Noise, Audible; Flaked; Noise, Audible
THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18238921 ↗InjuryOct 30, 2023Overheating of Device; Patient Device Interaction Problem; Overheating of Device; Patient Device Interaction Problem
IT WAS REPORTED THAT DURING SURGERY, THE 3 IN 1 SHAVER OVERHEATED AND BURNED THE PATIENTS ARM. THE PATIENT HAD A BURN IN THE SHAPE OF THE SHAVER ON THEIR ARM. THERE WAS NO DELAY IN THE PROCEDURE. DUE DILIGENCE IS IN PROCESS AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.
Patient problems: Burn(s)
MAUDE report 18030406 ↗MalfunctionJul 17, 2023Patient Device Interaction Problem; Patient Device Interaction Problem
IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR A REPORTABLE MALFUNCTION. THE INITIAL REPORT WAS CREATED IN ERROR AND SHOULD BE VOIDED.
Patient problems: Burn(s)
MAUDE report 17332883 ↗InjuryJun 21, 2023Overheating of Device; Patient Device Interaction Problem; Overheating of Device; Patient Device Interaction Problem
IT WAS REPORTED THAT ON MAY 24, 2023 DURING SURGERY THE RELIGN 3 IN 1 SHAVER 5.0MM CAUSED A BURN ON THE PATIENT. THE DEVICE WAS HOT TO THE TOUCH PER THE SURGEON. THE SUTURE IN THE PHOTO WAS NOT DUE TO THE BURN BUT FOR THE SURGERY. NO EXTRA SUTURE WAS NEEDED, HOWEVER, ADDITIONAL POST OP OINTMENT WAS APPLIED TO THE BURN SITE. AN ALTERNATE PRODUCT WAS NOT USED TO COMPLETE THE PROCEDURE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.
Patient problems: Burn(s); Laceration(s)
MAUDE report 17171090 ↗MalfunctionJun 7, 2023Flaked; Flaked
NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THE INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17077904 ↗
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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
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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