GOMCO 02-00-0500Recalls & reported problems
Allied Medical, LLC · 500S CIRC. CLAMP EX SMALL 1.1 · Class 2
All models of GOMCO (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00026072002292), received between Feb 12, 2025 and Aug 16, 2026 — classified as 4 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information7
Patient problems
- Genital Bleeding5
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryAug 16, 2026Insufficient Device Problem Information
Bleeding on the crushline of the foreskin, happening with new 1.1 clamps. ( could also be another size).
Patient problems: Genital Bleeding
MAUDE report 50267723 ↗InjuryAug 16, 2026Insufficient Device Problem Information
Bleeding on the crushline of the foreskin, happening with new 1.1 clamps. ( could also be another size).
Patient problems: Genital Bleeding
MAUDE report 50266699 ↗InjuryAug 16, 2026Insufficient Device Problem Information
Bleeding on the crushline of the foreskin, happening with new 1.1 clamps. ( could also be another size).
Patient problems: Genital Bleeding
MAUDE report 50266209 ↗InjuryAug 16, 2026Insufficient Device Problem Information
Bleeding on the crushline of the foreskin, happening with new 1.1 clamps; (could also be another size).
Patient problems: Genital Bleeding
MAUDE report 50263800 ↗MalfunctionMay 8, 2026Insufficient Device Problem Information
I RECENTLY ORDERED 5 NEW GOMCO 1.1 CIRCUMCISION DEVICES AT THE END OF (B)(6). THEY WERE PLACED IN ROTATION LAST WEEK AND I HAD A PHYSICIAN TO USE TWO OF THEM AND REPORTED THAT BOTH TIMES, THE DEVICE CAUSED A SMALL CUT TO THE FORESKIN WHILE IN USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25124643 ↗MalfunctionApr 9, 2026Insufficient Device Problem Information
MEDLINE REPORTED THE DOCTOR EXPERIENCED EXCESSIVE BLEEDING FOR THE PATIENT AND WOULD LIKE IT INVESTIGATED .
Patient problems: Genital Bleeding
MAUDE report 24830536 ↗MalfunctionFeb 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
I WANTED TO BRING TO YOUR ATTENTION THAT WE EXPERIENCED A MALFUNCTION WITH A GOMCO 1.1CM CLAMP DURING A RECENT PROCEDURE LAST WEEK. THIS IS NOT THE FIRST TIME THAT THEY HAVE ENCOUNTERED THIS ISSUE. THE CLAMP DID NOT COMPLETELY CLOSE, CAUSING THE SKIN TO SLIP THROUGH AND NOT COMPLETING THE CUT. I WAS UNABLE TO LOCATE A SERIAL NUMBER ON THE CLAMP, BUT THE MANUFACTURER DATE IS 20240126.
Patient problems: Insufficient Information
MAUDE report 21364364 ↗
Other Clamp, Circumcision devices
- Centurion CR230KCenturion Medical Products Corporation · CLAMP, CIRCUMCISION2 recalls0 reports
- Centurion CR3145KCenturion Medical Products Corporation · CLAMP, CIRCUMCISION2 recalls0 reports
- Centurion 330CRKCenturion Medical Products Corporation · CLAMP, CIRCUMCISION1 recall8 reports
- Centurion 310CRCenturion Medical Products Corporation · CLAMP, CIRCUMCISION1 recall4 reports
- Centurion 330CRCenturion Medical Products Corporation · CLAMP, CIRCUMCISION1 recall1 report
- Centurion CR345KCenturion Medical Products Corporation · CLAMP, CIRCUMCISION1 recall0 reports
- Centurion 3145CRCenturion Medical Products Corporation · CLAMP, CIRCUMCISION1 recall0 reports
- Centurion 345CRCenturion Medical Products Corporation · CLAMP, CIRCUMCISION1 recall0 reports
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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