Jelco 4293Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20351688058901), received between May 15, 2017 and Feb 12, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE MEDICATION SPILLS WERE CAUSED BY AN EXPLOSION. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326802 ↗
• MalfunctionJan 19, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DEVICE LEAKING OUT ALL AROUND THE HUB AND ALL MEDICATION WAS WASTED. THEY NEED TO RE-STICK THE PATIENT TO GIVE THE MEDICATION. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24111536 ↗
• MalfunctionAug 25, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING THE INJECTION OF LIDOCAINE, THE RADIOLOGIST WAS ADVANCING THE NEEDLE WITH LITTLE RESISTANCE WHEN THE NEEDLE SEPARATED FROM THE ORANGE HUB. PER REPORTER, THE NEEDLE WAS STILL IN THE PATIENT, BUT THE LIDOCAINE SPRAYED OUT WITH FORCE. PER REPORTER, ONE HAND WAS USED TO INJECT, AND THEY WERE ABLE TO RECONNECT AND TOOK THE NEEDLE OUT OF THE PATIENT AND PROCEED WITH THE PROCEDURE. THE TECHNOLOGIST STATED THE LIDOCAINE HIT THE LOWER FACE NEAR THE MOUTH AND DENIED THAT ANY GOT INTO THE MOUTH OR EYES. MEDICAL INTERVENTION WAS REQUIRED FOR THE EMPLOYEE THAT HAD TO GO TO EMPLOYEE HEALTH FOR AN EVALUATION. THE OUTCOME OF THE EVENT WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884505 ↗
• MalfunctionAug 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE MEDICATION LEAKED FROM THE TOP OF THE SYRINGE, AND THEN THE NEEDLE SEPARATED FROM THE SYRINGE AND REMAINED IN THE PATIENT'S ARM. THE PATIENT RECEIVED ANOTHER DOSE OF THE MEDICATION SINCE THE FIRST DOSE WAS INCOMPLETE. THE DEVICE WAS OPERATED BY A HEALTHCARE PROFESSIONAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22714831 ↗
• MalfunctionMay 6, 2025Fluid/Blood Leak; Premature Separation; Fluid/Blood Leak; Premature Separation

  IT WAS REPORTED THAT WHILE ADMINISTERING MEDICATION, NEEDLE POPPED OFF OF SHIELD WHILE DEPRESSING PLUNGER AND SPILLED THE MEDICATION. REDREW MEDICATION AND HAD TO POKE PATIENT A SECOND TIME. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971935 ↗
• InjuryAug 16, 2017Break; Break

  IT WAS REPORTED THAT THE NEEDLE OF A JELCO® HYPODERMIC NEEDLE-PRO® DEVICE "BROKE OFF". IT WAS NOTED THAT AN ADVERSE EVENT OCCURRED, HOWEVER DETAILS OF THE EVENT WERE NOT PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque; No Information

  MAUDE report 6797972 ↗
• InjuryAug 16, 2017Break; Break

  IT WAS ADDITIONALLY REPORTED THAT THE DEVICE WAS IN USE FOR JOINT INJECTIONS IN THE KNEE WITH THE DRUG ORTHOVISC. THE PLASTIC PART AT THE BASE OF THE NEEDLE BROKE CAUSING THE NEEDLE TO STAY IN THE PATIENT'S KNEE. THE NEEDLE WAS ABLE TO BE REMOVED WITHOUT HARM.

  Patient problems: Device Embedded In Tissue or Plaque; No Information

  MAUDE report 6797958 ↗
• MalfunctionMay 15, 2017Break; Detachment of Device or Device Component; Protective Measures Problem; Break; Detachment of Device or Device Component; Protective Measures Problem

  IT WAS REPORTED THAT THE NEEDLE OF A JELCO® HYPODERMIC NEEDLE-PRO® DEVICE DETACHED FROM THE SAFETY HOUSING UPON ATTEMPTING TO REMOVE AFTER INJECTION. THE NEEDLE BROKE OFF INSIDE THE PATIENT'S MUSCLE AND THE DOCTOR HAD TO PULL IT OUT BY HAND. NO INJURY TO PATIENT OR CLINICIAN WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6567163 ↗
• MalfunctionMay 15, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED THAT THE NEEDLE OF A JELCO® HYPODERMIC NEEDLE-PRO® DEVICE RELEASED FROM THE HUB AND REMAINED IN THE PATIENT DURING INJECTION PROCESS. NO INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6567156 ↗

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.