SUPERBAG PNI0240Recalls & reported problems
Dannik LLC · PMI SuperBag 10 Medium Specimen Retrieval System, 240mL · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10850013527615), received between Oct 4, 2024 and Oct 4, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. 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
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 4, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
PATIENT UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY. THE DEVICE, ENDO CATCH BAG, WAS USED TO CONTAIN THE SPECIMEN. AS THE BAG WAS BEING REMOVED FROM THE PATIENT, IT TORE, SPILLING GALL STONES IN TO THE ABDOMINAL CAVITY. THE GALL BLADDER WAS INTACT IN THE BAG. THE RUP WAS IRRIGATED AND SUCTIONED CLEAR AND THE BAG PIECES WERE REMOVED FROM THE CAVITY AS WELL. COMPARISON OF THE TORN BAG AND PIECES TO A COMPLETE BAG WAS DONE AS WELL TO ENSURE NO REMAINING BAG PIECES REMINED IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20370895 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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