3-in-1 SHAVER™ 4.2mm R-10008Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00859273007083), received between Sep 19, 2022 and Oct 29, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Flaked” (6 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Flaked; Flaked

  THERE IS NO ADDITIONAL INFORMATION AVAILABLE REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23414756 ↗
• MalfunctionMay 10, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19286984 ↗
• MalfunctionFeb 26, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING SURGERY MORE METAL FLAKES COMING OFF THE 4.2 RELIGN 3-IN-1 BLADES IN OSCILLATION MODE. NO HARM OR DELAY WERE REPORTED. DUE DILIGENCE INFORMATION IN PROCESS. NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18783996 ↗
• MalfunctionJan 22, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING SURGERY METAL SHAVINGS WERE COMING OFF THE SHAVER. THERE WAS A PATIENT INVOLVED BUT NO IMPACT, HARM, OR DELAY REPORTED. NO FOREIGN BODY WAS RETAINED BY PATIENT. DUE DILIGENCE INFORMATION COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18557183 ↗
• MalfunctionJan 17, 2024Flaked; Peeled/Delaminated; Patient Device Interaction Problem; Flaked; Peeled/Delaminated; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE 4.2MM RELIGN 3-IN-1 BLADES GIVING OFF METAL FLAKES/SHAVING INTO THE PATIENT DURING KNEE SCOPE. IT IS UNKNOWN AT THE MOMENT AS TO WHETHER ALL OF THE FLAKES WERE RECOVERED. THERE WAS NO REPORTED PATIENT HARM, OR DELAY. DUE DILIGENCE IS IN PROCESS, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18526104 ↗
• MalfunctionJan 17, 2024Flaked; Peeled/Delaminated; Patient Device Interaction Problem; Flaked; Peeled/Delaminated; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE 4.2MM RELIGN 3-IN-1 BLADES GIVING OFF METAL FLAKES/SHAVING INTO THE PATIENT DURING KNEE SCOPE. NO INFORMATION WAS PROVIDED AS TO WHETHER ALL OF THE FLAKES HAD BEEN REMOVED. THERE WAS NO REPORTED PATIENT HARM, OR DELAY. DUE DILIGENCE IS IN PROCESS, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18526099 ↗
• InjurySep 19, 2022Flaked; Patient-Device Incompatibility; Flaked; Patient-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY PIECES OF THE DEVICE CAME OFF AND ENTERED THE PATIENTS SURGERY SITE. IT IS UNKNOWN IF ALL PIECES WERE REMOVED. ANOTHER DEVICE WAS USED TO FINISH THE PROCEDURE AND AS A RESULT A DELAY OCCURRED IN WHICH THE PATIENT WAS UNDER ANESTHESIA. NO OTHER ADVERSE EVENTS WERE REPORTED AS IT RELATES TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 15447758 ↗