Jelco 4290Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 20351688046823), received between Apr 6, 2021 and May 15, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A HEPATITIS B VACCINE INJECTION TO THE PATIENT'S LEFT ARM, THE VACCINE SHOT AND NEEDLE PROTECTION DEVICE CAME APART FROM THE NEEDLE. THE NEEDLE WAS NOT SECURED INTO THE PROTECTION DEVICE. THE PATIENT DID NOT RECEIVE ANY OF THAT INJECTION. THE PATIENT WAS THEN GIVEN A SUCCESSFUL HEPATITIS B VACCINE INTO THE RIGHT UPPER ARM WITH ALL COMPONENTS FULLY INTACT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25192009 ↗
• MalfunctionFeb 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLE DISCONNECTED FROM SAFETY SHIELD AND PARTIAL AMOUNT OF MEDICINE DID NOT GET INJECTED INTO PATIENT. THIS RESULTED THE NEEDLE BEING STUCK IN THE SKIN WHILE THE SYRINGE WAS DETACHED FROM THE SAFETY SHIELD. THE NURSE WAS ABLE TO PULL THE NEEDLE OUT. THE PATIENT REQUIRED NO MEDICAL INTERVENTION AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21473818 ↗
• MalfunctionFeb 11, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PRODUCT RECEIVED DOES NOT MATCH THE PURCHASE ORDER DESCRIPTION. THE ORDER WAS FOR NEEDLE HYPODERMIC SAFETY 23G 25MM (1") BLUE PRO C500-065/PTX AND ORANGE ONES WERE RECEIVED. ADDITIONALLY, THE NEEDLES RECEIVED ARE PACKED IN INCORRECT PACKAGING WITH DETAILS OF BLUE NEEDLES - 23G, BUT ORANGE HAVE A 25G. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355630 ↗
• MalfunctionJan 9, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THERE WAS AN ISSUE IDENTIFIED WITH THE JELCO NEEDLE-PRO SYRINGES 23G GAUGES. THEY HAVE ORANGE COLORED NEEDLE PROTECTION DEVICES, WHICH IS ASSOCIATED WITH 25G NEEDLES. THE PHOTO OF THE NEEDLES IN THEIR PACKAGING MAKES IT DIFFICULT TO DISTINGUISH THEIR GAUGES. UPON CLOSER INSPECTION, AFTER REMOVING THE NEEDLES FROM THEIR PACKAGING AND COVERS, THEY FOUND THAT THE NEEDLES ARE BLUE. THE NHS SUPPLY CHAIN IMAGE SHOWS THAT THE NEEDLE PROTECTION SHOULD MATCH THE NEEDLE COLOR. THIS DISCREPANCY COULD LEAD TO INCIDENTS WITH PATIENTS IF THE WRONG NEEDLE IS USED. THERE WAS NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118729 ↗
• MalfunctionJan 9, 2025Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE NEEDLES ARE LOOSE AND FAILING AT THE HUB. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112465 ↗
• MalfunctionDec 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN PUSHING THE PLUNGER OF THE SYRINGE SOME MEDICATION WENT INTO THE PATIENT AND THE REST SQUIRTED OUT OF THE SIDES OF THE NEEDLE. WHEN CHECKING THE DEVICE COULD SEE THE NEEDLE WAS NOT PROPERLY SCREWED INTO THE PROTECTION DEVICE MEANING THE MEDICATION LEAKED THROUGH AT THIS POINT. THERE WAS PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026852 ↗
• MalfunctionNov 12, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT WHEN PUSHING DOWN ON THE SYRINGE TO GIVE A MEDICATION INJECTION, THE ENTIRE BODY OF THE SYRINGE POPPED OFF FROM THE NEEDLE WHILE THE NEEDLE REMAINED IN THE CHILD'S LEG. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20667741 ↗
• MalfunctionOct 9, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE NEEDLE BECAME SEPARATED FROM THE SYRINGE. THE PATIENT DIDN'T GET MEDICATIONS AND THE NEEDLE, AND THE SYRINGE WAS STUCK INTO THE PATIENT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408162 ↗
• MalfunctionOct 2, 2023Fluid/Blood Leak; Loose or Intermittent Connection; Air/Gas in Device; Fluid/Blood Leak; Loose or Intermittent Connection; Air/Gas in Device

  IT WAS REPORTED THAT THE NEEDLE WAS TOO LOOSE ON THE SAFETY SYSTEM, WHICH MEANT THAT AIR ENTERS THE SYRINGE WHEN IT IS DRAWN UP AND THAT FLUID LEAKS NEXT TO THE NEEDLE WHEN INJECTING. THE NEEDLE SPONTANEOUSLY COMES LOOSE FROM THE SAFETY SYSTEM DURING THE PUNCTURE. ADVERSE PATIENT EFFECTS ARE UNKNOWN. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17856484 ↗
• MalfunctionOct 2, 2023Fluid/Blood Leak; Loose or Intermittent Connection; Air/Gas in Device; Fluid/Blood Leak; Loose or Intermittent Connection; Air/Gas in Device

  IT WAS REPORTED THAT THE NEEDLE WAS TOO LOOSE ON THE SAFETY SYSTEM, WHICH MEANT THAT AIR ENTERS THE SYRINGE WHEN IT IS DRAWN UP AND THAT FLUID LEAKS NEXT TO THE NEEDLE WHEN INJECTING. THE NEEDLE SPONTANEOUSLY COMES LOOSE FROM THE SAFETY SYSTEM DURING THE PUNCTURE. ADVERSE PATIENT EFFECTS ARE UNKNOWN. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17856422 ↗
• MalfunctionOct 2, 2023Fluid/Blood Leak; Loose or Intermittent Connection; Air/Gas in Device; Fluid/Blood Leak; Loose or Intermittent Connection; Air/Gas in Device

  IT WAS REPORTED THAT THE NEEDLE WAS TOO LOOSE ON THE SAFETY SYSTEM, WHICH MEANT THAT AIR ENTERS THE SYRINGE WHEN IT IS DRAWN UP AND THAT FLUID LEAKS NEXT TO THE NEEDLE WHEN INJECTING. THE NEEDLE SPONTANEOUSLY COMES LOOSE FROM THE SAFETY SYSTEM DURING THE PUNCTURE. ADVERSE PATIENT EFFECTS ARE UNKNOWN. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17855946 ↗
• MalfunctionOct 2, 2023Fluid/Blood Leak; Loose or Intermittent Connection; Air/Gas in Device; Fluid/Blood Leak; Loose or Intermittent Connection; Air/Gas in Device

  IT WAS REPORTED THAT THE NEEDLE WAS TOO LOOSE ON THE SAFETY SYSTEM, WHICH MEANT THAT AIR ENTERS THE SYRINGE WHEN IT IS DRAWN UP AND THAT FLUID LEAKS NEXT TO THE NEEDLE WHEN INJECTING. THE NEEDLE SPONTANEOUSLY COMES LOOSE FROM THE SAFETY SYSTEM DURING THE PUNCTURE. ADVERSE PATIENT EFFECTS ARE UNKNOWN. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17855905 ↗
• MalfunctionOct 2, 2023Fluid/Blood Leak; Loose or Intermittent Connection; Air/Gas in Device; Fluid/Blood Leak; Loose or Intermittent Connection; Air/Gas in Device

  IT WAS REPORTED THAT THE NEEDLE WAS TOO LOOSE ON THE SAFETY SYSTEM, WHICH MEANT THAT AIR ENTERS THE SYRINGE WHEN IT IS DRAWN UP AND THAT FLUID LEAKS NEXT TO THE NEEDLE WHEN INJECTING. THE NEEDLE SPONTANEOUSLY COMES LOOSE FROM THE SAFETY SYSTEM DURING THE PUNCTURE. ADVERSE PATIENT EFFECTS ARE UNKNOWN. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 17855817 ↗
• MalfunctionAug 31, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE NEEDLE BROKE OFF AT THE HUB. THE NEEDLE BROKE EASILY WHEN BEING USED TO DRAW UP MEDICATION AND ADMINISTER VACCINES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15328128 ↗
• MalfunctionAug 30, 2022Break; Break

  IT WAS REPORTED THAT THE NEEDLE BROKE OFF AT THE HUB. THE NEEDLES BREAK OFF VERY EASILY WHEN USED TO DRAW UP MEDICATIONS AND ADMINISTER VACCINES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321617 ↗
• MalfunctionAug 30, 2022Break; Break

  IT WAS REPORTED THAT THE NEEDLE BROKE OFF AT THE HUB. THE NEEDLES BREAK OFF VERY EASILY WHEN USED TO DRAW UP MEDICATIONS AND ADMINISTER VACCINES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321606 ↗
• MalfunctionDec 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE NEEDLE AND HUB WAS NOT SECURELY ATTACHED TO THE NEEDLE SAFETY DEVICE, RESULTING IN VACCINE WASTE AND NEEDLE REMAINING IN PATIENT ARM.

  Patient problems: Insufficient Information

  MAUDE report 12964235 ↗
• MalfunctionMay 14, 2021Detachment of Device or Device Component

  BLUE NEEDLE BASE DETACHED FROM ORANGE SAFETY MECHANISM AND REMAINED IN PATIENT'S ARM AFTER VACCINE ADMINISTRATION. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 11831820 ↗
• MalfunctionApr 6, 2021Fluid/Blood Leak; Insufficient Flow or Under Infusion; Fluid/Blood Leak; Insufficient Flow or Under Infusion

  INVESTIGATION COMPLETED . NO PRODUCT WAS RETURNED, ATTACHED IN SME SUMMARY.

  Patient problems: Anaphylactic Shock

  MAUDE report 11624914 ↗

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.