Jelco 982306Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Jelco (101)
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 20351688059991), received between Sep 17, 2026 and Sep 18, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).
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 Leak3
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.
MalfunctionSep 18, 2026Fluid/Blood Leak
It was stated in the report that the nurse noticed that the extension tube was leaking blood during blood collection. There was patient involvement but no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819326 ↗MalfunctionSep 18, 2026Fluid/Blood Leak
It was stated in the report that the nurse noticed the plunger was leaking blood during blood collection. There was patient involvement but no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819093 ↗MalfunctionSep 17, 2026Fluid/Blood Leak
It was stated in the report that the extension tube was leaking blood. There was patient involvement and no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802256 ↗
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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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