Medline BTRDRecalls & reported problems
Medline Industries, Inc. · BLOOD TRANSFER DEVICE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10193489006087), received between Oct 18, 2024 and Sep 15, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Insufficient Device Problem Information1
- Loose or Intermittent Connection1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Exposure to Body Fluids1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Fluid/Blood Leak
Patient problems: Exposure to Body Fluids
MAUDE report 50780186 ↗MalfunctionSep 11, 2026Loose or Intermittent Connection; Material Integrity Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50735140 ↗MalfunctionOct 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
(B)(6) IN OUR LAB JUST LET ME KNOW THEY HAD AN INCIDENT THIS WEEKEND WITH A TRANSFER DEVICE THAT MALFUNCTIONED AND BLOOD WENT EVERYWHERE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20478306 ↗
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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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