Jelco 4275Recalls & reported problems
Icu Medical, Inc. · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20351688048964), received between Aug 29, 2022 and Oct 23, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Markings/Labelling Problem1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 23, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT AFTER REMOVING THE NEEDLES FROM THEIR PACKAGING AND COVERS, THEY FOUND THAT THE NEEDLES ARE GREY, WHEREAS THE 22 GAUGE SHOULD BE BLACK. THERE WAS UNKNOWN PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20514601 ↗MalfunctionAug 29, 2022Material Separation; Material Separation
IT WAS REPORTED THAT THE NEEDLE ROUTINELY FALLS OFF THE SAFETY LOCK, AND THE SAFETY LOCK IS FLIMSY AND BREAKS OFF EASILY WHEN BENDING IT AWAY FROM THE NEEDLE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15311067 ↗
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 SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.