Jelco 4430-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00351688070237), received between Jul 10, 2017 and Jul 10, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Bent” (2 reports).

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 16, 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.

• InjuryJul 10, 2017Bent; Protective Measures Problem; Bent; Protective Measures Problem

  HYPODERMIC NEEDLE-PRO® EDGE¿ SAFETY DEVICE FIXED NEEDLE TB SYRINGE BENT AND STUCK OUT OF THE SAFETY DEVICE. A DIRTY NEEDLE STICK OCCURRED. BLOOD BORNE PATHOGEN EXPOSURE PROTOCOL WAS STARTED. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 6698747 ↗
• MalfunctionJul 10, 2017Bent; Protective Measures Problem; Bent; Protective Measures Problem

  IT WAS REPORTED THAT IMMEDIATELY UPON USE OF THE DEVICE, THE NEEDLE OF A JELCO HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE FIXED NEEDLE TB SYRINGE BENT AND STUCK OUT OF THE SAFETY DEVICE. NO INJURY TO PATIENT OR CLINICIAN WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6698744 ↗

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-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-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-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
• 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