Jelco 4428-5Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00351688060979), received between Apr 4, 2017 and Apr 4, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Bent” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K063755); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2017Bent; Protective Measures Problem; Bent; Protective Measures Problem

  IT WAS REPORTED THAT A JELCO® HYPODERMIC NEEDLE-PRO® NEEDLE CAUSED A NEEDLESTICK INJURY TO A NURSE. THE NURSE HAD ENGAGED THE SAFETY DEVICE AFTER SUBCUTANEOUS ADMINISTRATION OF LIDOCAINE FOR INTRAVENOUS STICK AND LAID THE DEVICE ON THE BEDSIDE TABLE. IT WAS NOTED THAT THE NURSE FELT THE SAFETY CAP WAS ENGAGED. DURING CLEANUP OF THE TABLE, THE NURSE EXPERIENCED A SMALL PRICK ON THE LEFT PINKY FINGER WITH THE NEEDLE. IT WAS OBSERVED THAT THE NEEDLE WAS STICKING OUT OF THE SAFETY DEVICE AND SLIGHTLY BENT. THE NURSE WAS PUT THROUGH AN EXPOSURE PROTOCOL AND RESULTS WERE NEGATIVE. NO PERMANENT INJURY WAS REPORTED. THE EVENT WAS CONSIDERED RESOLVED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 6457415 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063755. One submission often covers many models, so check the product and lot details in each record.

• Z-1798-2021 · May 17, 2021 · Terminated
  JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G X 1/2" (0.33mm x 13mm), REF 4428-1 b) 1.0mL 29G X 1/2" (0.33mm x 13mm), REF 4429-1
• Z-0645-2014 · Jul 10, 2013 · Terminated
  Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED012905-IN Hypoder
• Z-0644-2014 · Jul 10, 2013 · Terminated
  Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in Reference: 4429-5 Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, lat
• Z-0646-2014 · Jul 10, 2013 · Terminated
  Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.5ml 29g x 1/2 in. Distributed by: Cardinal Health, Dublin, OH (Co-Brand) Reference: ED052905IN Hypode
• Z-0643-2014 · Jul 10, 2013 · Terminated
  Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 0.3ml 29g x 1/2 in Reference: 4429-3 Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, lat
• Z-0642-2014 · Jul 10, 2013 · Terminated
  Jelco Smiths Medical Hypodermic Needle-Pro Fixed Needle Insulin Syringe, 1.0ml 29g x 1/2 in Reference: 4429-1 Hypodermic Needle-Pro Fixed Needle Insulin Syringes are sterile, lat