Medical Action Industries 56779Recalls & reported problems
Medical Action Industries Inc. · Kit: Circumcision 20/Cs · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10809160006023), received between May 11, 2026 and May 18, 2026 — classified as 4 injuries, 6 malfunctions.
The most frequently reported specific device problem is “Defective Device” (6 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
- Defective Device6
- Contamination4
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
InjuryMay 18, 2026Contamination
THE CUSTOMER REPORTED ISSUES WITH THE 4 X 4 COTTON GAUZE CONTAINED WITHIN CIRCUMCISION CONVENIENCE KIT MANUFACTURED BY MEDICAL ACTION INDUSTRIES. DURING APPROXIMATELY NINE CIRCUMCISION CASES, SMALL COTTON FIBERS WERE OBSERVED SHEDDING FROM THE GAUZE, REQUIRING ADDITIONAL TIME TO REMOVE THEM TO PREVENT RETENTION AT THE SURGICAL SITE. NO PATIENT INJURIES WERE REPORTED AS A RESULT OF INCIDENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25203688 ↗InjuryMay 18, 2026Contamination
THE CUSTOMER REPORTED ISSUES WITH THE 4 X 4 COTTON GAUZE CONTAINED WITHIN CIRCUMCISION CONVENIENCE KIT MANUFACTURED BY MEDICAL ACTION INDUSTRIES. DURING APPROXIMATELY NINE CIRCUMCISION CASES, SMALL COTTON FIBERS WERE OBSERVED SHEDDING FROM THE GAUZE, REQUIRING ADDITIONAL TIME TO REMOVE THEM TO PREVENT RETENTION AT THE SURGICAL SITE. NO PATIENT INJURIES WERE REPORTED AS A RESULT OF INCIDENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25201155 ↗InjuryMay 18, 2026Contamination
THE CUSTOMER REPORTED ISSUES WITH THE 4 X 4 COTTON GAUZE CONTAINED WITHIN CIRCUMCISION CONVENIENCE KIT MANUFACTURED BY MEDICAL ACTION INDUSTRIES. DURING APPROXIMATELY NINE CIRCUMCISION CASES, SMALL COTTON FIBERS WERE OBSERVED SHEDDING FROM THE GAUZE, REQUIRING ADDITIONAL TIME TO REMOVE THEM TO PREVENT RETENTION AT THE SURGICAL SITE. NO PATIENT INJURIES WERE REPORTED AS A RESULT OF INCIDENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25201126 ↗InjuryMay 18, 2026Contamination
THE CUSTOMER REPORTED ISSUES WITH THE 4 X 4 COTTON GAUZE CONTAINED WITHIN CIRCUMCISION CONVENIENCE KIT MANUFACTURED BY MEDICAL ACTION INDUSTRIES. DURING APPROXIMATELY NINE CIRCUMCISION CASES, SMALL COTTON FIBERS WERE OBSERVED SHEDDING FROM THE GAUZE, REQUIRING ADDITIONAL TIME TO REMOVE THEM TO PREVENT RETENTION AT THE SURGICAL SITE. NO PATIENT INJURIES WERE REPORTED AS A RESULT OF INCIDENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25201124 ↗MalfunctionMay 12, 2026Defective Device
CURVED HEMOSTAT BROKE DURING CIRCUMCISION PROCEDURE. THE HEMOSTAT INSTRUMENT FAILED TO HOLD THE SKIN, COMING LOOSE. NO PATIENT HARM RESULTED FROM INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25155831 ↗MalfunctionMay 11, 2026Defective Device
STRAIGHT HEMOSTAT BROKE DURING CIRCUMCISION PROCEDURE. THE HEMOSTAT INSTRUMENT FAILED TO HOLD THE SKIN, COMING LOOSE. NO PATIENT HARM RESULTED FROM INCIDENT. SITE REPORTED THE HEMOSTAT FAILED 4-5 TIMES DURING 19 TOTAL CIRCUMCISIONS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25145142 ↗MalfunctionMay 11, 2026Defective Device
STRAIGHT HEMOSTAT BROKE DURING CIRCUMCISION PROCEDURE. THE HEMOSTAT INSTRUMENT FAILED TO HOLD THE SKIN, COMING LOOSE. NO PATIENT HARM RESULTED FROM INCIDENT. SITE REPORTED THE HEMOSTAT FAILED 4-5 TIMES DURING 19 TOTAL CIRCUMCISIONS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25145136 ↗MalfunctionMay 11, 2026Defective Device
STRAIGHT HEMOSTAT BROKE DURING CIRCUMCISION PROCEDURE. THE HEMOSTAT INSTRUMENT FAILED TO HOLD THE SKIN, COMING LOOSE. NO PATIENT HARM RESULTED FROM INCIDENT. SITE REPORTED THE HEMOSTAT FAILED 4-5 TIMES DURING 19 TOTAL CIRCUMCISIONS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25144986 ↗MalfunctionMay 11, 2026Defective Device
STRAIGHT HEMOSTAT BROKE DURING CIRCUMCISION PROCEDURE. THE HEMOSTAT INSTRUMENT FAILED TO HOLD THE SKIN, COMING LOOSE. NO PATIENT HARM RESULTED FROM INCIDENT. SITE REPORTED THE HEMOSTAT FAILED 4-5 TIMES DURING 19 TOTAL CIRCUMCISIONS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25144926 ↗MalfunctionMay 11, 2026Defective Device
STRAIGHT HEMOSTAT BROKE DURING CIRCUMCISION PROCEDURE. THE HEMOSTAT INSTRUMENT FAILED TO HOLD THE SKIN, COMING LOOSE. NO PATIENT HARM RESULTED FROM INCIDENT. SITE REPORTED THE HEMOSTAT FAILED 4-5 TIMES DURING 19 TOTAL CIRCUMCISIONS PERFORMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25144922 ↗
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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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