Jelco 4236Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20351688048827), received between Jun 5, 2024 and May 9, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CAP WAS SECURED TO NEEDLE AND WHEN ATTEMPTING TO ADMINISTER, THE MEDICATION SPRAYED OUT OF THE NEEDLE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21994581 ↗
• MalfunctionDec 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT MEDICATION WAS LEAKING BEYOND THE PLUNGER OF THE SYRINGE. THE FAULT OCCURRED DRAWING UP MEDICATIONS FROM THE SYRINGE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852922 ↗
• MalfunctionNov 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE MEDICATION LEAKED PAST THE BLACK PART OF THE PLUNGER OF THE SYRINGE, RESULTING IN THE LOSS OF HALF OF THE MEDICATION. THE ISSUE HAPPENED TO MULTIPLE NURSES AT DIFFERENT TIMES OVER THE LAST MONTH. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797848 ↗
• MalfunctionNov 4, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SYRINGE LEAKED WHILE DRAWING UP MEDICATION. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598869 ↗
• MalfunctionOct 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FLUID WAS LEAKING FROM A FILLED SYRINGE. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569196 ↗
• MalfunctionOct 23, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PARAMEDICS DREW UP MEDICATION ON TWO SEPARATE INCIDENTS AND NOTICED FLUID BEHIND THE PLUNGER. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20515711 ↗
• MalfunctionJun 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLES WERE LEAKING AT THE BLACK HUB. IT DID NOT HELP TO TIGHTEN THE NEEDLE OR NOT IT STILL LEAKS. THERE WAS PATIENT INVOLVEMENT DURING THE USE OF ADMINISTERING MEDICATION. NO PATIENT WAS HARM. NO MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19469307 ↗

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 · Terminated
  Jelco, 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.