Jelco 4234Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 20351688048803), received between May 3, 2024 and Jun 23, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS DIFFICULTLY DRAWING UP MEDICATIONS DUE TO LOW SUCTION. THE MEDICATION WOULD GET BEHIND THE BLACK STOPPER AND LEAKED FROM THE SYRINGE WHILE ATTEMPTING TO DO AN INTRAVENOUS PUSH. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310482 ↗
• MalfunctionJan 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT NON-NARCOTIC WAS DRAWN UP ON THE OPPOSITE SIDE OF THE PLUNGER RESULTING IN A LOSS OF MEDICATION TO THE PATIENT. THERE WAS A PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057850 ↗
• MalfunctionJan 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT NARCOTIC WAS DRAWN UP ON THE OPPOSITE SIDE OF THE PLUNGER, RESULTING IN A LOSS OF NARCOTICS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057571 ↗
• MalfunctionDec 31, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE IN USE WITH A PATIENT, THE MEDICATIONS BECAME DRAWN UP ON THE OPPOSITE SIDE OF THE DEVICE PLUNGER, CAUSING A LOSS OF MEDICATION. THERE HAS BEEN NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047973 ↗
• MalfunctionDec 6, 2024Leak/Splash; Leak/Splash

  IT WAS STATED THAT THE PLUNGER DOES NOT PROPERLY FIT IN THE SYRINGE BARREL. WHEN THEY DREW UP TORADOL, AIR WAS PULLED IN FROM SOMEWHERE ALONG WITH THE MEDICATION. WHEN THEY PUSHED THE AIR BACK INTO THE VIAL, TORADOL LEAKED AROUND THE PLUNGER AND ONTO THEIR GLOVED HAND. THEY WERE NOT ABLE TO GET THE FULL 1ML DOSE. THEN, THEY NEEDED TO USE A NEW SYRINGE AND A SECOND VIAL OF TORADOL. THIS ISSUE HAPPENED MULTIPLE TIMES WITH THE SAME PRODUCT. THEY EVENTUALLY USED A SPARE VIAL OF TORADOL AND A SPARE SYRINGE. THE AVAILABILITY OF THE DEVICE IS UNKNOWN. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20865060 ↗
• MalfunctionNov 27, 2024Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE MEDICATION LEAKED OUT OF THE BOTTOM OF THE SYRINGE. A NURSE DESCRIBED IT AS THE PLUNGER DID NOT SEEM SNUG IN THE BARREL OF THE SYRINGE, SO THE MEDICATION LEAKED OUT OF THE BOTTOM. MULTIPLE NURSES REPORTED LEAKING OF MEDICATION FROM SYRINGE WHEN DRAWING MEDICATION FROM VIAL. THEY HAD TO REDRAW MEDICINES FROM A NEW VIAL AND NEW SYRINGE. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798270 ↗
• MalfunctionAug 13, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKING OCCURRED THROUGH THE PLUNGER. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973859 ↗
• MalfunctionMay 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT NEEDLE HUBS APPEAR TO DISCONNECT EASILY DURING NORMAL USE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19299036 ↗
• MalfunctionMay 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLE HUBS APPEAR TO DISCONNECT EASILY DURING NORMAL USE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19298545 ↗
• MalfunctionMay 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE LEAKED MEDICATION BEFORE IT WAS GIVEN TO THE PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248135 ↗
• MalfunctionMay 3, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE DUE TO LEAKING THE MEDICATION BEFORE IT COULD BE DELIVERED TO THE PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19243236 ↗

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.