FMS OMNICUT 283346Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886705022489), received between Apr 24, 2019 and Jun 16, 2025 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionSep 1, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN SWITZERLAND THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THERE WERE METAL DUSTS WHILE USING THE OMNICUT 5.2 (USED W/ MICRO HANDPIECE) BLADE DEVICE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY. REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15338421 ↗
• MalfunctionMay 10, 2021Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE BLADE ON THE OMNICUT 5.2 RES BLADE 5PK DEVICE WAS DULL THAT IT DID NOT CLEAN THE JOINT PROPERLY WHILE IN USE WITH THE HANDPIECE DEVICE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797319 ↗
• MalfunctionMar 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT AN O-RING FELL OUT WHILE TRYING TO INSTALL IN THE SHAVER CONNECTOR DEVICE. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11455777 ↗
• InjuryJul 8, 2020Break; Break

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT DURING A SHOULDER ARTHROSCOPY ON AN UNKNOWN DATE, METAL SHAVINGS CAME LOOSE FROM THE HEAD OF AN OMNICUT 5.2 (USED W/ MICRO HANDPIECE). NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 10246196 ↗
• MalfunctionApr 24, 2019Packaging Problem; Packaging Problem

  DEVICE REPORT FROM MITEK (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PRIOR TO A SHOULDER REPAIR PROCEDURE THE OMNICUT 5.2 REUSABLE BLADE STERILE PACKAGING WAS DAMAGED. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO DELAY. ALTERNATIVES WERE READILY AVAILABLE. THIS REPORT IS FOR A OMNICUT 5.2 REUSABLE BLADE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546329 ↗
• MalfunctionApr 24, 2019Packaging Problem; Packaging Problem

  DEVICE REPORT FROM MITEK (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT PRIOR TO A SHOULDER REPAIR PROCEDURE THE OMNICUT 5.2 REUSABLE BLADE STERILE PACKAGING WAS DAMAGED. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO DELAY. ALTERNATIVES WERE READILY AVAILABLE. THIS REPORT IS FOR A OMNICUT 5.2 REUSABLE BLADE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8546316 ↗