Gyrus ACMI ST-CRRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00821925007857), received between Jul 30, 2021 and Apr 16, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Component Missing” (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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2026Device Damaged Prior to Use

  IT WAS REPORTED THE TRAY, SURGICAL, INSTRUMENT HAD CRACKED TRAY. THE EVENT HAD OCCURRED DURING OUT OF THE BOX FAILURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24901399 ↗
• MalfunctionJun 1, 2024Component Missing; Component Missing

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE STERILIZATION TRAY EXHIBITED THE STOPPER (INTERNAL TOOTH LOCK WASHER) THAT HOLDS ONE SIDE OF THE HANDLE ROD WAS MISSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19442635 ↗
• MalfunctionJun 28, 2023Crack; Crack

  COMPANY REPRESENTATIVE REPORTED WITH AN ISSUE OF STERILIZATION TRAY HAVE CRACKED. PER THE REPORT, TWO TRAYS HAVE CRACKED IN WHICH THE CUSTOMER ONLY BOUGHT THESE TRAYS BACK IN SEPTEMBER. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO USER INJURY WAS REPORTED. THIS EVENT INCLUDES TWO REPORTS : REPORT WITH PATIENT IDENTIFIER (B)(6) MODEL ST-CR, SN (B)(6) (TRAY 1 OF 2). REPORT WITH PATIENT IDENTIFIER (B)(6) MODEL ST-CR, SN (B)(6) (TRAY 2 OF 2). THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) MODEL ST-CR, SN (B)(6) (TRAY 2 OF 2).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17214196 ↗
• MalfunctionJun 28, 2023Crack; Crack

  COMPANY REPRESENTATIVE REPORTED WITH AN ISSUE OF STERILIZATION TRAY HAVE CRACKED. PER THE REPORT, TWO TRAYS HAVE CRACKED IN WHICH THE CUSTOMER ONLY BOUGHT THESE TRAYS BACK IN SEPTEMBER. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO USER INJURY WAS REPORTED. THIS EVENT INCLUDES TWO REPORTS : REPORT WITH PATIENT IDENTIFIER (B)(6) MODEL ST-CR, SN (B)(6) (TRAY 1 OF 2). REPORT WITH PATIENT IDENTIFIER (B)(6) MODEL ST-CR, SN (B)(6) (TRAY 2 OF 2). THIS REPORT BEING SUBMITTED IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) MODEL ST-CR, SN (B)(6) (TRAY 1 OF 2).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17214195 ↗
• MalfunctionApr 11, 2023Component Missing; Component Missing

  COMPANY REPRESENTATIVE IN BEHALF OF THE CUSTOMER REPORTED AN OUT OF BOX FAILURE. IT WAS REPORTED DEVICE WAS MISSING THE STOPPER THAT KEEPS THE HANDLE FROM FALLING OFF". ACCORDING TO THE REPORT, THE CUSTOMER STATED "THE BOX ARRIVED AND THERE WAS NO SIGN OF DAMAGE; HOWEVER, IT WAS DEFINITELY DAMAGED OUT OF THE BOX, CUSTOMER PER THE REPORT STATED THE STOPPER WAS NOT THERE TO START WITH PER THE OBSERVATION". THE ISSUE FOUND AT INSTALLATION. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16721381 ↗
• MalfunctionJul 30, 2021Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT DURING INSTALLATION, THE HANDLE WAS BROKEN ON THE LID. THERE WAS NO PATIENT INVOLVEMENT, NO USER INJURY REPORTED DUE TO THE EVENT. THIS REPORT IS BEING SUBMITTED FOR THE HANDLE WAS BROKEN ON THE LID, METAL ROD IS MISSING A WASHER ON EACH SIDE TO KEEP THE METAL ROD SECURELY IN POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12254082 ↗