Jelco 432310Recalls & 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
- 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 00351688069347), received between Apr 3, 2017 and Apr 3, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment Of Device Component” (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.
Most reported problems
Device problems
- Detachment Of Device Component1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2017Detachment Of Device Component; Detachment Of Device Component
IT WAS REPORTED THAT THE JELCO® HYPODERMIC NEEDLE-PRO® EDGE¿ SAFETY DEVICE "NEEDLE CLOSED SAFETY DEVICE AND HUB CAME OUT". NO PATIENT ADVERSE HEALTH OUTCOME WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6455217 ↗
Other SYRINGE, ANTISTICK devices
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- BD Integra 305271Becton, Dickinson And Company · SYRINGE, ANTISTICK106 reports
- BD Integra 305269Becton, Dickinson And Company · SYRINGE, ANTISTICK85 reports
- BD Luer-Lok, BD SafetyGlide 305924Becton, Dickinson And Company · SYRINGE, ANTISTICK1 recall28 reports
- BD Integra 305272Becton, Dickinson And Company · SYRINGE, ANTISTICK71 reports
- BD SafetyGlide 305945Becton, Dickinson And Company · SYRINGE, ANTISTICK63 reports
- BD SafetyGlide 305950Becton, Dickinson And Company · SYRINGE, ANTISTICK61 reports
- Medline SYRS103225Medline Industries, Inc. · SYRINGE, ANTISTICK1 recall0 reports
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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