GOMCORecalls & reported problems across all models
Allied Medical, LLC · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 3 models of GOMCO by Allied Medical, LLC in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Apr 29, 2022 and Aug 16, 2026 — classified as 4 injuries, 24 malfunctions.
The most frequently reported specific device problem is “Product Quality Problem” (15 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
Reports received per month, all models
Most reported GOMCO problems
Device problems
- Product Quality Problem15
- Insufficient Device Problem Information8
- No Apparent Adverse Event2
- Nonstandard Device2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- Genital Bleeding5
- Hemorrhage/Blood Loss/Bleeding1
- Insufficient Information1
GOMCO models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GOMCO 02--01-0500Clamp, Circumcision19 reports
- GOMCO 02-00-0500Clamp, Circumcision7 reports
- Gomco G180Apparatus, Suction, Ward Use, Portable, Ac-Powered2 reports
Recent GOMCO adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJan 30, 2026No Apparent Adverse Event
MalfunctionJan 30, 2026No Apparent Adverse Event
AS PER CLIENT, THE CIRCUMCISION CLAMPS THEY ORDERED SEEM TO BE DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24225331 ↗MalfunctionOct 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
THE CUSTOMER REMOVED THE MANUFACTURER DATE STICKERS TO STERILIZE THE CLAMP PRIOR TO USE AND THEY SAID THE FINISH CAME OFF WITH THE STICKER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23328893 ↗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 ↗MalfunctionJan 17, 2025Product Quality Problem; Product Quality Problem
DISTRIBUTOR IS REPORTING THAT THEIR CUSTOMER /CUSTOMERS ARE REPORTING THAT THEY ARE NOT GETTING A SMOOTH CUT AROUND THE BELL, CUTTING THE FORESKIN IS NOT EAST AND IS CAUSING CONCERN FROM THEIR DOCTORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21180456 ↗MalfunctionJan 17, 2025Product Quality Problem; Product Quality Problem
DISTRIBUTOR IS REPORTING THAT THEIR CUSTOMER /CUSTOMERS ARE REPORTING THAT THEY ARE NOT GETTING A SMOOTH CUT AROUND THE BELL, CUTTING THE FORESKIN IS NOT EAST AND IS CAUSING CONCERN FROM THEIR DOCTORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21180454 ↗MalfunctionJan 17, 2025Product Quality Problem; Product Quality Problem
DISTRIBUTOR IS REPORTING THAT THEIR CUSTOMER /CUSTOMERS ARE REPORTING THAT THEY ARE NOT GETTING A SMOOTH CUT AROUND THE BELL, CUTTING THE FORESKIN IS NOT EAST AND IS CAUSING CONCERN FROM THEIR DOCTORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21180453 ↗MalfunctionJan 17, 2025Product Quality Problem; Product Quality Problem
DISTRIBUTOR IS REPORTING THAT THEIR CUSTOMER /CUSTOMERS ARE REPORTING THAT THEY ARE NOT GETTING A SMOOTH CUT AROUND THE BELL , CUTTING THE FORESKIN IS NOT EAST AND IS CAUSING CONCERN FROM THEIR DOCTORS .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21180448 ↗MalfunctionJan 17, 2025Product Quality Problem; Product Quality Problem
DISTRIBUTOR IS REPORTING THAT THEIR CUSTOMER /CUSTOMERS ARE REPORTING THAT THEY ARE NOT GETTING A SMOOTH CUT AROUND THE BELL, CUTTING THE FORESKIN IS NOT EAST AND IS CAUSING CONCERN FROM THEIR DOCTORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21180447 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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