MEDLINE MDS9900025KRecalls & reported problems
Medline Industries, Inc. · CLAMP, MOGEN, CIRCUMCISION · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10197344003075), received between Sep 2, 2026 and Sep 30, 2026 — classified as 15 malfunctions.
The most frequently reported specific device problem is “Sharp Edges” (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
- Sharp Edges6
- Nonstandard Device5
- Difficult to Open or Close3
- Mechanical Problem2
Patient problems
- Laceration(s)10
- Hemorrhage/Blood Loss/Bleeding5
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Mechanical Problem
Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)
MAUDE report 50950054 ↗MalfunctionSep 28, 2026Mechanical Problem
It was reported that "WHEN MOGEN PULLED BACK TO ADJUST PLACEMENT, THERE APPEARED TO BE A LACERATION ON THE LEFT SIDE OF THE NEWBORNS PENIS DURING CIRCUMCISION."
Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)
MAUDE report 50915873 ↗MalfunctionSep 24, 2026Nonstandard Device
Patient problems: Laceration(s)
MAUDE report 50885189 ↗MalfunctionSep 22, 2026Sharp Edges
It was reported that "The flat pieces of this device that actually touches the foreskin have a sharp edge on them. When the physician clamps down on the foreskin, it cuts the skin by just closing the clamp. It cuts it on the underside of the penis."
Patient problems: Laceration(s)
MAUDE report 50855299 ↗MalfunctionSep 21, 2026Nonstandard Device
Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)
MAUDE report 50839462 ↗MalfunctionSep 7, 2026Nonstandard Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50650136 ↗MalfunctionSep 4, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50618832 ↗MalfunctionSep 4, 2026Sharp Edges
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50617305 ↗MalfunctionSep 3, 2026Sharp Edges
Patient problems: Laceration(s)
MAUDE report 50595753 ↗MalfunctionSep 3, 2026Nonstandard Device
Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)
MAUDE report 50595629 ↗MalfunctionSep 3, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50595542 ↗MalfunctionSep 3, 2026Nonstandard Device; Sharp Edges
Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)
MAUDE report 50589804 ↗MalfunctionSep 3, 2026Sharp Edges
It was reported that "the blade has cut the skin below where the clamp is placed. He says there is a sharp edge that is cutting the patient."
Patient problems: Laceration(s)
MAUDE report 50589142 ↗MalfunctionSep 2, 2026Sharp Edges
Patient problems: Laceration(s)
MAUDE report 50568249 ↗MalfunctionSep 2, 2026Difficult to Open or Close
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50566188 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page