Jelco 972112Recalls & 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 00351688060450), received between Sep 15, 2025 and Sep 15, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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
- Material Separation3
- Disconnection2
Patient problems
- Needle Stick/Puncture3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2025Disconnection; Material Separation; Disconnection; Material Separation
IT WAS REPORTED THAT THE PRODUCT HAS MULTIPLE ISSUES SUCH AS THE PRODUCT COMING APART, THE NEEDLE'S SAFETY COVER WAS NOT IN PLACE AND BEING STUCK BY THE NEEDLE. THE PATIENT WAS INVOLVEMENT AND INJURY, BUT NO PATIENT HARM WAS REPORTED.
Patient problems: Needle Stick/Puncture
MAUDE report 23057921 ↗MalfunctionSep 15, 2025Disconnection; Material Separation; Disconnection; Material Separation
IT WAS REPORTED THAT THE PRODUCT HAS MULTIPLE ISSUES SUCH AS THE PRODUCT COMING APART, THE NEEDLE'S SAFETY COVER WAS NOT IN PLACE AND BEING STUCK BY THE NEEDLE. THERE WAS PATIENT INVOLVEMENT AND INJURY, BUT NO HARM REPORTED.
Patient problems: Needle Stick/Puncture
MAUDE report 23057911 ↗MalfunctionSep 15, 2025Material Separation; Material Separation
IT WAS REPORTED THAT THE PRODUCT HAS MULTIPLE ISSUES SUCH AS THE PRODUCT COMING APART, THE NEEDLE'S SAFETY COVER WAS NOT IN PLACE AND BEING STUCK BY THE NEEDLE. THERE WAS PATIENT WAS INVOLVEMENT AND INJURY, BUT NO HARM WAS REPORTED.
Patient problems: Needle Stick/Puncture
MAUDE report 23057867 ↗
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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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