Medline-Microtek Drainage BagsRecalls & reported problems
Microtek Medical LLC · Patient Drape, Lingeman Cysto / Uro Drain Bag - Skyton / Steris / Picker Tables · Class 1
Data updated Oct 18, 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 00748426144266), received between Oct 17, 2025 and Oct 17, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- Exposure to Body Fluids1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 17, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING INTRAOPERATIVE USE OF THE DRAINAGE BAG, FLUID LEAKED ONTO CLINICAL STAFF, RESULTING IN DIRECT EXPOSURE TO BLOOD AND SPILLAGE ONTO THE FLOOR. THE SPILLAGE IMPEDED ACCURATE TRACKING OF HYSTEROSCOPIC FLUID USAGE. STAFF REPORTED THE BAG IS CHALLENGING TO POSITION/OPERATE INTRAOPERATIVELY. IN SOME CASES, NURSES/TECHS NEEDED TO PHYSICALLY LIFT PATIENTS TO PLACE THE BAG UNDER THE BUTTOCKS, CREATING POTENTIAL ERGONOMIC INJURY RISK. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.
Patient problems: Exposure to Body Fluids
MAUDE report 23330532 ↗
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