Jelco 402310Recalls & reported problems
Icu Medical, Inc. · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00351688066520), received between Dec 5, 2024 and Mar 25, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Disconnection” (4 reports).
4 other recalls cover devices cleared under the same FDA submission (K041399); 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
- Disconnection4
- Break1
- Leak/Splash1
- Retraction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 25, 2025Break; Retraction Problem; Break; Retraction Problem
IT WAS REPORTED THAT WHEN THE NEEDLE WAS RETRACTED A CLICK WAS HEARD BUT A PORTION OF THE NEEDLE REMAINED EXPOSED. IT WAS ALSO INFORMED THAT LIST INFORMING THAT IT HAS EXACT SAME FAILURE TO FULLY ENGAGE SAFELY AND BOTH RESULTED IN CLINICIAN'S NEEDLE STICKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21688890 ↗MalfunctionMar 25, 2025Disconnection; Disconnection
IT WAS REPORTED THAT PEDIATRICS TEAM HAD BEEN EXPERIENCING NEEDLES FALLING OFF PREFILLED SYRINGES ¿ SPECIFICALLY FOR FLU SHOT SYRINGES. NEEDLES SEEMINGLY UNSCREWED THEMSELVES AND FELL OFF. THE EVENT OCCURRED DURING REMOVAL/ AT THE END OF THERAPY. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21687820 ↗MalfunctionMar 20, 2025Disconnection; Disconnection
IT WAS REPORTED THAT PEDIATRICS TEAM HAD BEEN EXPERIENCING NEEDLES FALLING OFF PREFILLED SYRINGES ¿ SPECIFICALLY FOR FLU SHOT SYRINGES. NEEDLES SEEMINGLY UNSCREWED THEMSELVES AND FELL OFF. THE EVENT OCCURRED DURING REMOVAL/ AT THE END OF THERAPY. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21659841 ↗MalfunctionMar 20, 2025Disconnection; Disconnection
IT WAS STATED THAT PEDIATRICS TEAM HAD BEEN EXPERIENCING NEEDLES FALLING OFF PREFILLED SYRINGES ¿ SPECIFICALLY FOR FLU SHOT SYRINGES. NEEDLES SEEMINGLY UNSCREWED THEMSELVES AND FELL OFF. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21657683 ↗MalfunctionDec 5, 2024Disconnection; Leak/Splash; Disconnection; Leak/Splash
IT WAS REPORTED THAT THE NEEDLES FELL OFF WHEN THEY WERE GIVEN ON PATIENTS. THIS HAPPENED AFTER THE ADMINISTRATION OF THE DEVICES AND THERE WERE TWO NEEDLES REPORTED HAVING THIS ISSUE. THE PATIENTS WERE REPORTED NOT TO BE IMPACTED. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20859330 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K041399. One submission often covers many models, so check the product and lot details in each record.
- Z-1733-2019 · Feb 11, 2019 · TerminatedSmith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration o
- Z-0898-2015 · Nov 21, 2014 · CompletedHypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Needle Pro Edge Safety Hypodermic Needle is intend
- Z-0899-2015 · Nov 21, 2014 · CompletedHypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe; Reorder Number: 452010 Product Usage: The Needle Pro Edge Safety Hypodermic Needle is intended
- Z-0897-2015 · Nov 21, 2014 · CompletedHypodermic Needle Pro Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro Edge Safety Hypodermic Needle is intended for injection or aspiration of flu
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- 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.