Jelco 4277Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20351688051254), received between Jul 12, 2024 and Jun 19, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 reports).
1 other recall cover devices cleared under the same FDA submission (K923127); they may or may not involve this specific model.
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
- Detachment of Device or Device Component4
- Fluid/Blood Leak1
- Misconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE NEEDLES WERE BREAKING WITH THE SAFETY DEVICE OFF CAUSING THE NEEDLE TO GET STUCK IN THE SKIN. THERE WERE NO INJURIES OR ADVERSE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292408 ↗MalfunctionJun 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE NEEDLES WERE BREAKING WITH THE SAFETY DEVICE OFF CAUSING THE NEEDLE TO GET STUCK IN THE SKIN. THERE WERE NO INJURIES OR ADVERSE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292326 ↗MalfunctionJun 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE NEEDLES WERE BREAKING WITH THE SAFETY DEVICE OFF CAUSING THE NEEDLE TO GET STUCK IN THE SKIN. THERE WERE NO INJURIES OR ADVERSE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22289357 ↗MalfunctionJun 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE NEEDLES WERE BREAKING WITH THE SAFETY DEVICE OFF CAUSING THE NEEDLE TO GET STUCK IN THE SKIN. THERE WERE NO INJURIES OR ADVERSE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22289345 ↗MalfunctionOct 21, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT WHILE INJECTING INTO A PATIENT THE NEEDLE DISLODGED FROM THE HUB/PROTECTIVE COVERING MECHANISM CAUSING SPRAY INTO STAFF MEMBERS EYES. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20498685 ↗MalfunctionJul 12, 2024Misconnection; Misconnection
IT WAS REPORTED THAT WHILE INJECTING THE PATIENT THE NEEDLE DISLODGED FROM THE HUB/PROTECTIVE COVERING MECHANISM. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19735185 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K923127. One submission often covers many models, so check the product and lot details in each record.
- Z-2670-2017 · Apr 4, 2017 · TerminatedJelco, Hypodermic needle Pro needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.
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- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 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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