CARDINAL HEALTH ED12905-INRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517065596), received between Jun 2, 2017 and Jun 28, 2017 — classified as 2 injuries.

The most frequently reported specific device problem is “Protective Measures Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryJun 28, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE NURSE EXPERIENCED A DIRTY NEEDLE STICK WHILE RE-CAPPING A JELCO® HYPODERMIC NEEDLE-PRO® INSULIN SYRINGE. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 6673511 ↗
• InjuryJun 2, 2017Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT WHEN PICKING UP A USED JELCO® HYPODERMIC NEEDLE-PRO® FIXED NEEDLE INSULIN SYRINGE, THE NURSE EXPERIENCED A NEEDLE STICK. THE NURSE HAD USED THE DESK TOP TO ENGAGE THE SAFETY DEVICE AFTER COMPLETING THE INJECTION. THE NURSE WENT ON TO COMPLETE THE "MED PASS", INCLUDING A SECOND INJECTION. AFTER COMPLETION, THE NURSE PICKED UP BOTH SYRINGES AT THE SAME TIME TO DISCARD, WHICH IS WHEN THE NEEDLE STICK OCCURRED. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 6609322 ↗

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-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-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
• 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-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-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