Jelco 4286Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20351688046793), received between Feb 16, 2017 and Mar 28, 2017 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 28, 2017Detachment of Device or Device Component; Protective Measures Problem; Detachment of Device or Device Component; Protective Measures Problem

  IT WAS REPORTED THAT A JELCO® HYPODERMIC NEEDLE-PRO® NEEDLE DETACHED FROM THE ORANGE SAFETY HOUSING DURING INJECTION ATTEMPT INTO THE GLUTEAL MUSCLE OF A PATIENT. THE DEPOT INJECTION WAS CONDUCTED BY A CERTIFIED PEDIATRIC NURSE AND THE ISSUE AROSE WHEN THE NURSE PRESSED ON THE SYRINGE PLUNGER. THE CONTENTS OF THE SYRINGE LEAKED ALL OVER THE PATIENT'S SKIN DUE TO THE ISSUE. THE NURSE HAD TO HOLD ONTO THE NEEDLE AND GENTLY REMOVE IT FROM THE PATIENT. ANOTHER NEEDLE WAS USED TO ADMINISTER THE MEDICATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6439307 ↗
• MalfunctionFeb 16, 2017Disconnection; Disconnection

  IT WAS REPORTED THAT WHILE USING THE HYPODERMIC NEEDLE PRO IN THE INTRAMUSCULAR (GLUTEAL MUSCLE) THE PLUNGER SEEPAGE WAS NOTED AND ON WITHDRAWAL FROM BUTTOCK THE NEEDLE DETACHED FROM THE NEEDLE PROTECTION DEVICE. THEREFORE NEEDLE WAS THEN REMOVED, NURSING STAFF UNABLE TO TELL HOW MUCH OF DEPOT WAS ACTUALLY GIVEN DUE TO SEEPAGE AND NEEDLE BREAKING OFF. NO PHYSICAL INJURY NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6337358 ↗

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.