Jelco EL1915Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20351688075670), received between Jan 22, 2026 and Apr 21, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 24939131 ↗
• MalfunctionApr 2, 2026Complete Blockage

  IT WAS REPORTED THAT DURING INFUSION THE TIP WAS CLOGGED AND THE MEDICINE DID NOT COME OUT OF THE SYRINGE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769598 ↗
• 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 24732591 ↗
• MalfunctionFeb 24, 2026Material Separation

  IT WAS STATED THAT THE NURSE PREPARED THE SUSPENSION ACCORDING TO THE INSTRUCTIONS, DREW IT INTO A SYRINGE, AND BEGAN TO INJECT THE PATIENT. DURING THE INJECTION, THE NEEDLE DETACHED/SNAPPED FROM ITS BASE AND THE SOLUTION SPLASHED EVERYWHERE, INCLUDING ON THE NURSE'S FACE, BUT NOT IN THEIR EYES. ACCORDING TO THE DOCTOR'S ASSESSMENT, THE PATIENT WAS GIVEN AN EXTRA DOSE AND THE NURSE GOT AWAY WITH A SCARE. THE INCIDENT TOOK PLACE IN A HOSPITAL. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429206 ↗
• MalfunctionJan 22, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS A DETACHED NEEDLE. AN AUSTRALIAN PHARMACY (FACILITY DETAILS NOT PROVIDED) REPORTED INCIDENT INVOLVING OLANZAPINE DEPOT INJECTION WHERE A FAULTY NEEDLE WAS IDENTIFIED AFTER ADMINISTRATION. A PATIENT CAME IN FOR THEIR REGULAR MONTHLY OLANZAPINE 405 MG INJECTION. THE INJECTION WAS PREPARED AND GIVEN AS USUAL. AFTER THE INJECTION, THE NEEDLE CAME OFF THE SYRINGE, LEAVING THE NEEDLE IN THE PATIENT. THE NEEDLE WAS SAFELY REMOVED, AND THE PATIENT WAS NOT HARMED. THE NEEDLE WAS DISPOSED OF BY THE PHARMACY AFTER USE AND WAS NOT RETAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24158150 ↗

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.