Gyrus ACMI GF-558Recalls & reported problems
Gyrus ACMI, LLC · 4-Prong Grasping Forceps 5 Fr. (1.67 mm), 58 cm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925002432), received between Jun 25, 2021 and Jun 25, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (1 report).
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
Device problems
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2021Defective Device; Defective Device
THE USER FACILITY REPORTED THAT PRIOR TO PROCESSING, THE EQUIPMENT WAS FOUND BROKEN. THE USER OPENED THE PACKAGE AND NOTICED THAT THE GRASPER WAS BROKEN. THE ISSUE OCCURRED PRIOR TO A STENT REMOVAL PROCEDURE. THE SAME DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY OR HARM WAS REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12070622 ↗
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- Sklar Instruments 96-2549Sklar Corporation · FORCEPS, GENERAL & PLASTIC SURGERY1 recall2 reports
- Centurion I68420Centurion Medical Products Corporation · FORCEPS, GENERAL & PLASTIC SURGERY1 recall2 reports
- Centurion 66440Centurion Medical Products Corporation · FORCEPS, GENERAL & PLASTIC SURGERY1 recall1 report
- Centurion 66195Centurion Medical Products Corporation · FORCEPS, GENERAL & PLASTIC SURGERY1 recall1 report
- Centurion 67310Centurion Medical Products Corporation · FORCEPS, GENERAL & PLASTIC SURGERY1 recall1 report
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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