GOMCO 02--01-0500Recalls & reported problems
Allied Medical, LLC · 500 CIRC. CLAMP, NEW BORN 1.3 · Class 2
All models of GOMCO (3)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00026072002308), received between Apr 29, 2022 and Jan 30, 2026 — classified as 19 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, 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.
Reports received per month
Most reported problems
Device problems
- Product Quality Problem15
- No Apparent Adverse Event2
- Adverse Event Without Identified Device or Use Problem1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions18
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
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 ↗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 ↗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 21180446 ↗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 21180445 ↗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 21180444 ↗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 21180443 ↗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 21180442 ↗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 21180441 ↗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 21180440 ↗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 21180439 ↗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 21180438 ↗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 21180437 ↗MalfunctionApr 29, 2022Adverse Event Without Identified Device or Use Problem
THE DOCTOR USED ONE OF THESE CLAMPS IN A PROCEDURE. THE DOCTOR NOTICED THAT THERE WAS MORE BLEEDING THAN USUAL, AND HE NEEDED TO USE MORE SUTURES THAN USUAL.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 14255015 ↗
Other Clamp, Circumcision devices
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- 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 230CRCenturion Medical Products Corporation · CLAMP, CIRCUMCISION1 recall0 reports
- Centurion 310CRKCenturion 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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