Jelco SB5021Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20351688073928), received between Jul 3, 2024 and Apr 21, 2026 — classified as 6 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K923127); 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLE CAME LOOSE DURING DRUG ADMINISTRATION. PER REPORTER, THE PART THAT BECOMES LOOSE IS LOCATED ABOVE THE ORANGE PROTECTIVE CAP. IT INVOLVES BOTH THE NEEDLE AND THE SMALL HARD PIECE TO WHICH THE NEEDLE IS ATTACHED. THE NEEDLE CAN BE ATTACHED SECURELY BY TWISTING IT INTO THE ORANGE PROTECTIVE CAP, WHERE IT THEN STAYS IN PLACE. REPORTER STATED THE PATIENT RECEIVED ONLY 0.2 ML, AS THE NEEDLE DETACHED UNDER PRESSURE DURING THE INJECTION. IT WAS DECIDED TO ADMINISTER ANOTHER 210 MG INJECTION TWO DAYS LATER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24939167 ↗
• MalfunctionApr 2, 2026Complete Blockage

  IT WAS REPORTED THAT A HEALTH CARE PROFESSIONAL REPORTED THAT DURING INFUSION THE TIP WAS CLOGGED AND THE MEDICINE DID NOT COME OUT OF THE SYRINGE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769617 ↗
• MalfunctionMar 30, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT WHEN A NURSE WAS ABOUT TO ADMINISTER A DEPOT INJECTION, BEFORE THE GIVEN AMOUNT OF 2.7 ML WAS INJECTED, THE NEEDLE DETACHED FROM THE SYRINGE. 1.7 ML HAD THEN BEEN INJECTED AND THERE WAS 1 ML REMAINING IN THE SYRINGE. THE SYRINGE TIP CAME LOOSE FROM THE SYRINGE. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24730117 ↗
• MalfunctionMar 26, 2026Obstruction of Flow

  IT WAS REPORTED THAT THE NEEDLE EXHIBITED A BLOCKAGE DURING INFUSION. THERE WAS DIFFICULTY INJECTING THE MEDICATION. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24705068 ↗
• MalfunctionMar 6, 2026Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT THE LOT NUMBER ON THE PACKAGING WAS MISREAD DUE TO A WHITE LINE RUNNING THROUGH IT. THE ACTUAL LOT NUMBER WAS 6064784 AND WAS MISREAD AS 6061781. APPROXIMATELY 50% OF THE NEEDLES HAD UNCLEAR LOT NUMBERS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24532863 ↗
• MalfunctionJul 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN THE MEDICATION WAS BEING ADMINISTERED TO THE PATIENT THE METAL NEEDLE BECAME DETACHED FROM THE PLASTIC SAFETY HOLDING DEVICE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669531 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923127. One submission often covers many models, so check the product and lot details in each record.

• Z-2670-2017 · Apr 4, 2017 · Terminated
  Jelco, Hypodermic needle Pro needles 19G X1 1/2" 800/CA Model No. EL 1915 & 19G X 2" 600/CA Model No. SB 5021, Rx Only, Sterile EO.