Jelco 4140Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10351688024565), received between Oct 30, 2024 and Jan 5, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT WHEN THEY USED THE TRANSFER DEVICE, IT DID NOT TRANSFER INTO THE TUBE AND INSTEAD SPRAYED AROUND AND OUTSIDE THE TRANSFER DEVICE. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND THERE WAS UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23968177 ↗
• MalfunctionJan 5, 2026Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT WHEN THEY USED THE TRANSFER DEVICE, IT DID NOT TRANSFER INTO THE TUBE AND INSTEAD SPRAYED AROUND AND OUTSIDE THE TRANSFER DEVICE. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND THERE WAS UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23967955 ↗
• MalfunctionNov 20, 2025Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THEY HAD AN INCIDENT IN THE LAB. THEY HAD A STRAIGHT NEEDLE COME OFF THE HUB WHILE DRAWING BLOOD ON A PATIENT. THERE ARE 70 BAGS AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23604799 ↗
• MalfunctionJul 21, 2025Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE DEVICES ARE A SAFETY CONCERN BECAUSE WHEN THEY SECURE THEM, BLOOD SPLASHES OUT. THE EVENT TOOK PLACE AT THE PHLEBOTOMY STATION AND HAPPENED TO MULTIPLE PATIENTS. THERE WAS NO ONE WAS REPORTED BEING HARMED/INJURED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22561201 ↗
• MalfunctionDec 9, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE NEEDLE SEPARATED FROM THE HUB DURING THE PHLEBOTOMY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878655 ↗
• MalfunctionDec 9, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE NEEDLE SEPARATED FROM THE HUB DURING THE PHLEBOTOMY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20878648 ↗
• MalfunctionNov 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLE-PRO SAFETY DEVICE DETACHED FROM THE NEEDLE DURING A BLOOD DRAW AND LEFT THE NEEDLE IN THE PATIENT'S ARM WHEN THE SAFETY DEVICE WAS PULLED AWAY. THIS OCCURRED TWO SEPARATE TIMES. THIS REPORT WAS CREATED TO CAPTURE THE FIRST PATIENT MENTIONED CHRONOLOGICALLY IN THE REPORT, WITH AN UNKNOWN EVENT DATE. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640572 ↗
• MalfunctionNov 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLE-PRO SAFETY DEVICE DETACHED FROM THE NEEDLE DURING A BLOOD DRAW AND LEFT THE NEEDLE IN THE PATIENT'S ARM WHEN THE SAFETY DEVICE WAS PULLED AWAY. THIS OCCURRED TWO SEPARATE TIMES. THIS REPORT WAS CREATED TO CAPTURE THE SECOND PATIENT MENTIONED CHRONOLOGICALLY IN THE REPORT, WITH THE KNOWN EVENT DATE. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20640571 ↗
• MalfunctionOct 30, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT THE DEVICE HAD PROBLEMS. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20568087 ↗