FMS OMNICUTRecalls & reported problems across all models

We found 2 models of FMS OMNICUT by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 36 adverse event reports in the FDA's MAUDE database, received between Sep 6, 2018 and Aug 12, 2026 — classified as 1 injury, 35 malfunctions.

The most frequently reported specific device problem is “Break” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported FMS OMNICUT problems

FMS OMNICUT models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• FMS OMNICUT 283345

  ARTHROSCOPE
  24 reports
• FMS OMNICUT 283346

  ARTHROSCOPE
  12 reports

Recent FMS OMNICUT adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Device Contaminated During Manufacture or Shipping

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50219578 ↗
• MalfunctionMay 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THAT THE OMNICUT 4.2 RES BLADE DEVICE DETACHED FROM THE SHAVER AND FELL OFF WHEN IT WAS REMOVED FROM THE PORTAL. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125069 ↗
• MalfunctionJan 27, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, THE OMNICUT 4.2 RES BLADE 5PK WAS BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189729 ↗
• MalfunctionOct 22, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, AFTER OPENING THE OMNICUT 4.2 RES BLADE DEVICE, A WHITE FOREIGN OBJECT WAS FOUND ON THE TIP AND FAT APPEARED TO HAVE SOLIDIFIED. THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360544 ↗
• MalfunctionJun 16, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, WHILE UNPACKING THE OMNICUT 5.2 RES BLADE DEVICE, IT WAS OBSERVED THAT "WHITE MUD" WAS OBSERVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO DELAY TO THE PROCEDURE. THERE WERE NO FRAGMENTS GENERATED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2025. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211045 ↗
• MalfunctionOct 4, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE APPEARANCE OF A SLIGHTLY LIQUID WHITE POWDER WAS SEEN WHEN OPENING (5) OMNICUT 5.2 RES BLADE, (4) ULTRA AGGRESSIVE PLUS 4.0MM, (13) ULTRA AGGRESSIVE PLUS 5.0. IT IS NOT CLEAR IF ALL (22) DEVICES WERE INVOLVED IN THE INCIDENT AND/OR IF THE USER EXPERIENCED THE SAME FAILURE FOR EACH DEVICE; THEREFORE, A REPORT WILL BE SUBMITTED FOR EACH DEVICE UNTIL FURTHER CLARIFICATION IS RECEIVED. THERE WERE NO SURGICAL DELAYS OR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 13 OF 22 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372539 ↗
• MalfunctionOct 4, 2024Device Contaminated During Manufacture or Shipping; Appropriate Device Problem Term/Code Not Available; Device Contaminated During Manufacture or Shipping; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE APPEARANCE OF A SLIGHTLY LIQUID WHITE POWDER WAS SEEN WHEN OPENING (5) OMNICUT 5.2 RES BLADE, (4) ULTRA AGGRESSIVE PLUS 4.0MM, (13) ULTRA AGGRESSIVE PLUS 5.0. IT IS NOT CLEAR IF ALL (22) DEVICES WERE INVOLVED IN THE INCIDENT AND/OR IF THE USER EXPERIENCED THE SAME FAILURE FOR EACH DEVICE; THEREFORE A REPORT WILL BE SUBMITTED FOR EACH DEVICE UNTIL FURTHER CLARIFICATION IS RECEIVED. THERE WERE NO SURGICAL DELAYS OR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 17 OF 22 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372344 ↗
• MalfunctionOct 4, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED FROM FRANCE THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE APPEARANCE OF A SLIGHTLY LIQUID WHITE POWDER WAS SEEN WHEN OPENING (5) OMNICUT 5.2 RES BLADE, (4) ULTRA AGGRESSIVE PLUS 4.0MM, (13) ULTRA AGGRESSIVE PLUS 5.0. IT IS NOT CLEAR IF ALL (22) DEVICES WERE INVOLVED IN THE INCIDENT AND/OR IF THE USER EXPERIENCED THE SAME FAILURE FOR EACH DEVICE; THEREFORE, A REPORT WILL BE SUBMITTED FOR EACH DEVICE UNTIL FURTHER CLARIFICATION IS RECEIVED. THERE WERE NO SURGICAL DELAY OR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 5 OF 22 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372274 ↗
• MalfunctionOct 4, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED FROM FRANCE THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE APPEARANCE OF A SLIGHTLY LIQUID WHITE POWDER WAS SEEN WHEN OPENING (5) OMNICUT 5.2 RES BLADE, (4) ULTRA AGGRESSIVE PLUS 4.0MM, (13) ULTRA AGGRESSIVE PLUS 5.0. IT IS NOT CLEAR IF ALL (22) DEVICES WERE INVOLVED IN THE INCIDENT AND/OR IF THE USER EXPERIENCED THE SAME FAILURE FOR EACH DEVICE; THEREFORE, A REPORT WILL BE SUBMITTED FOR EACH DEVICE UNTIL FURTHER CLARIFICATION IS RECEIVED. THERE WERE NO SURGICAL DELAY OR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 11 OF 22 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20372256 ↗
• MalfunctionSep 16, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED FROM JAPAN THAT DURING A ROTATOR CUFF REPAIR OF THE SHOULDER JOINT PROCEDURE THE OMNICUT 4.2 RES BLADE DEVICE WHEN THE PRODUCT WAS OPENED, THERE WAS A WHITE COTTON-LIKE SUBSTANCE LODGED IN THE TIP, WHICH WAS CHANGED TO A NEW ONE BEFORE USE. THE PRODUCT WAS NOT USED AND WAS NOT PLACED IN THE BODY. THE NEWLY OPENED ONE COULD BE USED NORMALLY, SO THERE WAS NO PROBLEM. THERE WAS NO SURGICAL DELAY AND NO HARM TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20225198 ↗
• MalfunctionMay 8, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED FROM JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE WHEN THE SURGEON ATTEMPTED TO ATTACH THE OMNICUT 4.2 RES BLADE 5PK DEVICE TO THE HANDPIECE DEVICE IT DID NOT FIT, NO MATTER HOW MANY TIMES HE TRIED. IT WAS REPORTED THAT ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR SURGICAL DELAY. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19273730 ↗
• MalfunctionMay 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT PRIOR TO AN UNKNOWN PROCEDURE AN UNKNOWN SHAVER DEVICE WAS BEING USED WHEN ATTEMPTING TO ATTACH THE TWO (X2) OMNICUT 4.2 RES BLADE SHAVERS IN QUESTION TO THE HANDPIECE; HOWEVER, NEITHER OF THE TWO SHAVERS FIT IN THE HANDPIECE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19231832 ↗
• MalfunctionMay 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT PRIOR TO AN UNKNOWN PROCEDURE AN UNKNOWN SHAVER DEVICE WAS BEING USED WHEN ATTEMPTING TO ATTACH THE TWO (X2) OMNICUT 4.2 RES BLADE SHAVERS IN QUESTION TO THE HANDPIECE; HOWEVER, NEITHER OF THE TWO SHAVERS FIT IN THE HANDPIECE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19231828 ↗
• MalfunctionApr 18, 2023Device Damaged Prior to Use; Device Contaminated During Manufacture or Shipping; Device Damaged Prior to Use; Device Contaminated During Manufacture or Shipping

  PART DETACHED AND WATER DROPS IN PACKAGE. IT WAS REPORTED BY THE DISTRIBUTOR IN CHINA THAT DURING INCOMING INSPECTION, IT WAS OBSERVED THAT THERE WERE WATER DROPS INSIDE THE UNOPENED PACKAGING OF THE OMNICUT 4.2 (USED W/ MICRO HANDPIECE) DEVICE. IT WAS FURTHER REPORTED THAT THE PLASTIC RING WAS DETACHED. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763505 ↗
• MalfunctionDec 16, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SWEDEN THAT DURING AN ARTHROSCOPIC SHOULDER SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THERE WAS LOOSENING OF METAL PIECES FROM THE OMNICUT 5.2 (USED W/ MICRO HANDPIECE) DEVICE. REMOVED ALL THE METAL FRAGMENTS WERE REMOVED SUCCESSFULLY FROM THE PATIENT. IT WAS UNKNOWN IF AND HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15995635 ↗

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