Jelco 4427-TBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00351688064489), received between Sep 22, 2022 and Sep 22, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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.

• MalfunctionSep 22, 2022Dull, Blunt; Failure to Obtain Sample; Dull, Blunt; Failure to Obtain Sample

  IT WAS REPORTED THAT IT WAS ALMOST IMPOSSIBLE TO DRAW UP AN ENTIRE DOSE OF BLOOD DUE TO SLOWNESS OF THE PRODUCT CAUSING AIR BUBBLES. DEVICE DID NOT SEEM SHARP AFTER INSERTING INTO THE HEPARIN VIAL. PATIENTS HAVE BEEN COMPLAINING THAT THE NEEDLE HURTS MORE THAN PREVIOUS TUBERCULOSIS (TB) NEEDLES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15462510 ↗
• MalfunctionSep 22, 2022Dull, Blunt; Failure to Obtain Sample; Dull, Blunt; Failure to Obtain Sample

  IT WAS REPORTED THAT IT WAS ALMOST IMPOSSIBLE TO DRAW UP AN ENTIRE DOSE OF BLOOD DUE TO SLOWNESS OF THE PRODUCT CAUSING AIR BUBBLES. DEVICE DID NOT SEEM SHARP AFTER INSERTING INTO THE HEPARIN VIAL. PATIENTS HAVE BEEN COMPLAINING THAT THE NEEDLE HURTS MORE THAN PREVIOUS TUBERCULOSIS (TB) NEEDLES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15462465 ↗

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-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-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-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-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