Detachable endo pocket FEP936116Recalls & reported problems
Unimax Medical Systems Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04714127863504), received between Jun 24, 2025 and Aug 19, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (3 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jun 25, 2024Class IIOpen, Classified
The tube may fall into the surgical site during the grasping process.
Z-3164-2024 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Break3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2025Break; Break
THE BAG BROKE WHILE TRYING TO RETRIEVE GALLBLADDER. THERE WERE NO PARTS OF BAG RETAINED IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22837442 ↗MalfunctionAug 11, 2025Break; Break
THE BAG BROKEN WHILE REMOVING GALLBLADDER FROM PATIENT. NEW BAG OPENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22769149 ↗MalfunctionJun 24, 2025Break; Break
DURING PROCEDURE WHEN DR. WAS ATTEMPTING TO REMOVE THE GALLBLADDER IN THE ENDO CATCH BAG THE BAG BROKE INSIDE OF PATIENT. BAG WAS FULLY RECOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22324982 ↗
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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 · each recall links to the FDA recall notice
- 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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