Jelco EL31915Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00351688072545), received between Apr 6, 2022 and Sep 2, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50573028 ↗
• MalfunctionApr 21, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLE CAME LOOSE DURING DRUG ADMINISTRATION. PER REPORTER, THE PART THAT BECOMES LOOSE IS LOCATED ABOVE THE ORANGE PROTECTIVE CAP. IT INVOLVES BOTH THE NEEDLE AND THE SMALL HARD PIECE TO WHICH THE NEEDLE IS ATTACHED. THE NEEDLE CAN BE ATTACHED SECURELY BY TWISTING IT INTO THE ORANGE PROTECTIVE CAP, WHERE IT THEN STAYS IN PLACE. REPORTER STATED THE PATIENT RECEIVED ONLY 0.2 ML, AS THE NEEDLE DETACHED UNDER PRESSURE DURING THE INJECTION. IT WAS DECIDED TO ADMINISTER ANOTHER 210 MG INJECTION TWO DAYS LATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938930 ↗
• MalfunctionMar 30, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT WHEN A NURSE WAS ABOUT TO ADMINISTER A DEPOT INJECTION, BEFORE THE GIVEN AMOUNT OF 2.7 ML WAS INJECTED, THE NEEDLE DETACHED FROM THE SYRINGE. 1.7 ML HAD THEN BEEN INJECTED AND THERE WAS 1 ML REMAINING IN THE SYRINGE. THE SYRINGE TIP CAME LOOSE FROM THE SYRINGE. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24734864 ↗
• MalfunctionMar 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A DETACHED NEEDLE. IN ONE CASE A NURSE NOTICED THAT THE NEEDLE DETACHED BEFORE ADMINISTRATION. THE NURSE HAD NO CONTACT WITH THE SOLUTION; THE PATIENT RECEIVED THE FULL DOSE. IN A SECOND CASE A NURSE EXPERIENCED THE NEEDLE DETACHING WITH APPROXIMATELY 0.5 ML REMAINING IN THE SYRINGE, AS A RESULT THE NURSE GOT IN DIRECT CONTACT WITH THE SOLUTION; THE PATIENT RECEIVED A PARTIAL DOSE. THE NEEDLE WAS REMOVED. THERE WAS NO REPORTED PATIENT HARM OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691712 ↗
• MalfunctionDec 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE COMPLAINT IS ABOUT A DETACHED NEEDLE. AFTER THE DOSE HAD BEEN DELIVERED, AS THE NURSE WENT TO REMOVE THE SYRINGE/NEEDLE FROM THE PATIENT, THE SYRINGE WAS REMOVED BUT THE NEEDLE REMAINED IN THE PATIENT. THERE WAS THEN A NEEDLE STICK INJURY TO A MEMBER OF STAFF WHEN TRYING TO REMOVE THE NEEDLE FROM THE PATIENT¿S INJECTION SITE. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23921472 ↗
• MalfunctionDec 10, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT WHILE DRAWING UP, THE NEEDLE SHAFT DISCONNECTED FROM NEEDLE HUB DUE TO FAULT WITH NEEDLE, CAUSING RECONSTITUTION TO SPILL SO UNABLE TO DRAW UP REQUIRED DOSE. IT WAS REPORTED THAT THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23768678 ↗
• MalfunctionNov 25, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE SYRINGE BECAME BLOCKED WHEN THE PATIENT WAS INJECTED. THERE WAS REPORTED PATIENT INVOLVEMENT, BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23647135 ↗
• MalfunctionOct 28, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING ADMINISTRATION, THE NURSE WAS UNABLE TO INJECT THE PRODUCT AS THE SYRINGE APPEARED TO BE BLOCKED. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23404026 ↗
• MalfunctionOct 28, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE PISTON BECAME BLOCKED AND THE NEEDLE DISLODGED, PREVENTING THE INJECTION OF THE PRODUCT AND RESULTING IN ITS LOSS. THE INCIDENT OCCURRED DURING ADMINISTRATION. THERE WAS A PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23403903 ↗
• MalfunctionSep 15, 2025Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT AFTER THE ADMINISTRATION OF THE PRODUCT, THE NEEDLE OF THE SYRINGE REMAINED IN THE PATIENT¿S MUSCLE. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23059030 ↗
• MalfunctionApr 6, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE TIP OF THE SYRINGE IS SKEWED RESULTING IN IMPROPER NEEDLE ATTACHMENT. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14021487 ↗

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.