PlastiBell Circumcision Device 9211Recalls & reported problems
Aspen Surgical Products, Inc. · 1.1 cm PlastiBell Circumcision Device · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840113231546), received between Jul 16, 2025 and Sep 9, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
- Separation Failure1
Patient problems
- Hemorrhage/Blood Loss/Bleeding3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
COMPLAINANT ALLEGES "DEVICE USED DURING CIRCUMCISION. PATIENT WAS DISCHARGED HOME. SUBSEQUENTLY PRESENTED TO THE EMERGENCY DEPARTMENT WITH POST-PROCEDURE BLEEDING. INITIAL EVALUATION NOTED A LACERATION TO THE GLANS PENIS DISTAL TO THE PLASTIBELL DEVICE; OBSERVATION WAS RECOMMENDED. LATER DURING HOSPITALIZATION, CONCERN AROSE THAT THE DEVICE HAD MIGRATED DISTALLY, POTENTIALLY COMPROMISING BLOOD FLOW. THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR DEVICE REMOVAL. INTRAOPERATIVELY, BLEEDING AND WORSENING HEMATOMA WERE NOTED. PATIENT WAS DISCHARGED HOME WITHOUT FURTHER KNOWN COMPLICATIONS."
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23009006 ↗InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
COMPLAINANT ALLEGES "CIRC PERFORMED ON 6/5. RETUNED WITHIN 12 HOURS OF THE CIRC WITH BLEEDING AND HEAD OF PENIS WAS SWOLLEN IN IT HAD TO BE SURGICALLY REMOVED."
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22521009 ↗InjuryJul 16, 2025Separation Failure; Separation Failure
COMPLAINANT ALLEGES "THE CIRCUMCISION WAS PERFORMED ON 6/6, INFANT DISCHARGED ON 6/7 WITH NORMAL ASSESSMENT POST CIRCUMCISION. INFANT RETURNED TO (B)(6) ED TODAY 6/17, DUE TO BLEEDING. UPON ASSESSMENT, THERE WAS AN ADHESION HOLDING THE PLASTIBELL ON, ONCE THE NNP WAS ABLE TO REMOVE THE ADHESION THE PLASTIBELL FELL OFF, NNP HELD PRESSURE AND BLEEDING RESOLVED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 22520217 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.