Jelco 4429-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00351688060948), received between Jul 10, 2017 and Sep 11, 2022 — classified as 1 injury, 5 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2022Display Difficult to Read; Display Difficult to Read

  IT WAS REPORTED THAT THE NUMBERS ARE SMUDGED MAKING VOLUME DIFFICULT TO READ. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397971 ↗
• MalfunctionApr 13, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT WHEN THE NURSE CAPPED THE SYRINGE, THE NEEDLE WENT THROUGH THE ORANGE CAP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102890 ↗
• MalfunctionJan 10, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  QUALITY DEFECT, THE BARREL MARKINGS ARE ASKEW ON THE BARREL OF THE SYRINGE. THE EVEN NUMBERS ON THE SCALE ARE SQUARELY ALIGNED BUT THE ODD NUMBERS ARE SKEWED APPROXIMATELY 20 DEGREES UPWARD. CONCERNED THAT THE CUSTOMER WOULD REJECT THE LOT FEAR OF MISS-DOSING PATIENTS. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 11144337 ↗
• MalfunctionJan 7, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A CUSTOMER STATES THE EVEN NUMBERS GRADUATION MARKS QUALITY IS SLANTED CAUSING CONCERN FROM THE CLINICIANS ON DOSING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 11129386 ↗
• InjuryJul 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. A DIRTY NEEDLESTICK OCCURRED. BLOOD BORNE PATHOGEN EXPOSURE PROTOCOL WAS STARTED. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 6698721 ↗
• 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 6698714 ↗

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-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-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-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