Jelco 402510Recalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 00351688066544), received between Feb 28, 2017 and May 12, 2026 — classified as 2 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (63 reports).

4 other recalls cover devices cleared under the same FDA submission (K041399); 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 25 most recent of 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PERSON WITH DIABETES (PWD) EXPERIENCED MEDICATION LEAKAGE AT THE HUB OF THE SYRINGE DURING INJECTIONS, RESULTING IN THE MEDICATION NOT BEING DELIVERED INTO THE PWD DESPITE CONFIRMATION THAT THE NEEDLE WAS SECURELY TIGHTENED. THERE WAS A PATIENT INVOLVEMENT WITH NO REPORTED HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25151260 ↗
• MalfunctionMar 24, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT MEDICATION LEAKED OUT OF THE HUB OF THE NEEDLE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM OR INTERVENTION REQUIRED. THE OUTCOME OF THE EVENT WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673816 ↗
• MalfunctionDec 23, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHEN THE MEDICAL ASSISTANT WENT TO PUSH THE VACCINE THROUGH THE SYRINGE, THE FLUID CAME OUT AT THE BASE OF THE SYRINGE AND ROLLED DOWN THE PATIENT'S ARM. THE MEDICAL ASSISTANT WAS CONFIDENT THAT THE END OF THE SYRINGE HAD NO OPENING, AND THE PATIENT DID NOT GET ANY OF THE MEDICINE. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE OUTCOME OF THE EVENT WAS RESOLVED; THEY USED ANOTHER PRODUCT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882833 ↗
• MalfunctionDec 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN ATTEMPTING TO ENGAGE THE SAFETY DEVICE ON THE NEEDLE, AFTER ADMINISTRATION TO A PATIENT, THE NURSE ATTEMPTED TO ENGAGE THE SAFETY MECHANISM, WHICH LED THE NEEDLE TO POPPED OFF THE SYRINGE, FELL, AND PUNCTURED THE NURSE'S HAND. HE NEEDLESTICK WAS SUPERFICIAL SO THERE WAS NO MEDICAL INTERVENTION NEEDED FOR THE PUNCTURE WOUND. THERE WAS NO BREAKING OF THE SYRINGE OR NEEDLE AT ANY POINT IN TIME. THERE WERE UNKNOWN PATIENT HARMS OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23772034 ↗
• MalfunctionDec 3, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE HUB WAS CRACKED, AND THE VACCINE LEAKED OUT, SO ANOTHER DOSE WAS DRAWN AND A NEW NEEDLE WAS USED BEFORE VACCINE ADMINISTRATION. THERE WAS NO PATIENT HARM AND NO MEDICAL INTERVENTION REQUIRED. THE OUTCOME WAS RESOLVED BY VACCINE REDRAWN/READMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23704649 ↗
• MalfunctionOct 28, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PREVNAR 20 MEDICATION WAS LEAKING FROM NEEDLE PRIOR TO ADMINISTRATION. THE PATIENT DID NOT RECEIVE FULL DOSE OF MEDICATION. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23405021 ↗
• MalfunctionOct 23, 2025Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLE WAS SCREWED ON THE SYRINGE, AND WHEN PUSHING SALINE INTO THE VACCINE, THE NEEDLE SHOT OFF OF THE SYRINGE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23368282 ↗
• MalfunctionJul 15, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE DEVICE HUB WAS CRACKED, AND THE VACCINE LEAKED OUT, SO ANOTHER DOSE WAS DRAWN AND A NEW NEEDLE WAS USED BEFORE VACCINE ADMINISTRATION. THERE WAS NO PATIENT HARM AND NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22512203 ↗
• MalfunctionMay 20, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE MEDICATION SQUIRTED OUT THE SIDE OF THE NEEDLE. THEY HAD CLEARED THE AIR FROM SYRINGE PRIOR, AND NO LEAK WAS NOTED. THERE WAS NO COMPLAIN ABOUT PAIN FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22049460 ↗
• MalfunctionMay 15, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT FLUID SPEWED FROM A VERTICAL CRACK IN THE NEEDLE HUB THAT ATTACHED TO THE SYRINGE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027054 ↗
• MalfunctionMay 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN THE OPERATOR OF THE DEVICE PUSHED ON THE PLUNGER, THE LIQUID CAME OUT AT THE SIDE OF THE SYRINGE AND ONTO THE PATIENT'S ARM AND SHIRT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965070 ↗
• MalfunctionMay 1, 2025Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT THE SAFETY MECHANISM OF THE DEVICE MALFUNCTIONED THAT RESULTED TO SOMEONE BEING STUCK. THERE WAS NO REPORTED PATIENT INVOLVEMENT, HOWEVER SOMEONE HAS BEEN STUCK BY THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942504 ↗
• MalfunctionFeb 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN ATTEMPTING TO ENGAGE THE SAFETY DEVICE ON THE NEEDLE, AFTER ADMINISTRATION TO A PATIENT, THE NURSE ATTEMPTED TO ENGAGE THE SAFETY MECHANISM, WHICH LED THE NEEDLE TO POPPED OFF THE SYRINGE, FELL, AND PUNCTURED THE NURSE'S HAND. HE NEEDLESTICK WAS SUPERFICIAL SO THERE WAS NO MEDICAL INTERVENTION NEEDED FOR THE PUNCTURE WOUND. THERE WAS NO BREAKING OF THE SYRINGE OR NEEDLE AT ANY POINT IN TIME. THERE WERE UNKNOWN PATIENT HARMS OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21406328 ↗
• MalfunctionJan 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH MW5163240 THAT THE MEDICATION SQUIRTED BEING TIGHT CONNECTED TO THE NEEDLE. THERE WAS A PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21137339 ↗
• MalfunctionJan 10, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA MEDWATCH 4326210 THAT THE NURSE WAS GIVING FLU VACCINE HIGH DOSE AND VACCINE LEAKED OUT OF SYRINGE. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124846 ↗
• MalfunctionJan 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT "FLUID SHOT OUT THE SIDE OF THE SYRINGE". THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21054955 ↗
• MalfunctionDec 31, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FLU VACCINE LEAKED FROM THE NEEDLE, NECESSITATING A SECOND INJECTION FOR THE PATIENT. THIS ISSUE OCCURRED THREE TIMES IN ONE DAY. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21047607 ↗
• MalfunctionDec 30, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLE HUB BROKE WHILE FILLED WITH VACCINE. THIS HAS CAUSED THE VACCINE TO LEAK OUT PRIOR TO OR DURING ADMINISTRATION LEADING TO INADEQUATE VACCINATION OF PATIENTS AND AN EMPLOYEE WHO HAD AN EXPOSURE OF THE VACCINE TO HER EYE. DEVICE IS AVAILABLE FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21040450 ↗
• MalfunctionDec 30, 2024Crack; Fluid/Blood Leak; Loose or Intermittent Connection; Crack; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THERE WAS A LOOSENING OR FRACTURE AT THE HUB BETWEEN THE NEEDLE AND SYRINGE, CAUSING LEAKAGE AND AN INABILITY TO INJECT THE VACCINE. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21035921 ↗
• MalfunctionDec 27, 2024Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT 25-GAUGE, 1 INCH NEEDLE HAS CAUSED A BREAK IN THE HUB OF PRE-FILLED VACCINE SYRINGES. THIS HAS CAUSED THE VACCINE TO LEAK OUT PRIOR TO OR DURING ADMINISTRATION LEADING TO INADEQUATE VACCINATION OF PATIENTS AND AN EMPLOYEE WHO HAD AN EXPOSURE OF THE VACCINE TO HER EYE. FOR PATIENT¿S ADMINISTRATION OF A SECOND DOSE OF VACCINE. FOR THE EMPLOYEE, FLUSHING OF EYES AND FOLLOW UP FROM CAREGIVER HEALTH TO DETERMINE IF FURTHER FOLLOW UP WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026218 ↗
• MalfunctionDec 9, 2024Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT THE PRODUCT WAS LEAKING WHEN THEY WERE PUSHING THE SYRINGE PLUNGER. FOUND A CRACK IN THE HUB PART OF THE NEEDLE. PATIENTS HAD BEEN NEEDING TO GET MULTIPLE NEEDLE INSERTIONS WHEN A NEEDLE LEAKS AND THE DOSE NEEDED TO BE ADMINISTERED WAS NOT GIVEN BECAUSE THE NEEDLE WAS LEAKING. THE REPORTED PRODUCT FAULT OCCURRED WHILE ADMINISTERING AN INJECTION. THE EVENT OCCURRED WHILE IN USE WITH THE PATIENT. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20879451 ↗
• MalfunctionDec 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN ADMINISTERING A PATIENTS' INFLUENZA VACCINE, THE VACCINE ITSELF STARTED COMING OUT THE PLASTIC PIECE OF THE SYRINGE AND NOT THROUGH THE NEEDLE AND DISPENSED INTO PATIENTS' ARM AS NORMAL. EMPLOYEE VERIFIED NEEDLE WAS APPROPRIATELY TIGHTENED TO SYRINGE WHEN ATTACHING TO THE VACCINE. WHEN LOOKING AT THE NEEDLE, THE HOLE ITSELF APPEARED SMALLER THAN OTHER NEEDLES IN THE SAME BOX. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT INJURY/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20867419 ↗
• MalfunctionDec 6, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLES WERE LEAKING AS WELL AS BREAKING OFF THE SYRINGE. WE ALSO RECEIVED REPORTS OF HEALTH PROVIDERS STICKING PATIENTS WITH THE NEEDLES AND THEN UPON RETRACT, THEY WERE BREAKING AND GETTING STUCK WITHIN THE PATIENTS. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20866162 ↗
• MalfunctionDec 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE RN WAS ADMINISTERING A FLU SHOT IN THE RIGHT ARM WHEN THE VACCINE SHOT OUT FROM THE NEEDLE OR THE NEEDLE CONNECTION. THE RN DID NOT FEEL OR HEAR A SNAP OR POP WHEN CONNECTING THE NEEDLE TO THE VACCINE. THE VACCINE PRIMED APPROPRIATELY, AND THE HUB WAS NOT OVERLY TIGHTENED. THERE WAS A PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20865293 ↗
• MalfunctionDec 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING ADMINISTRATION OF TWO INFLUENZA VACCINES (ADULT AND PEDIATRIC DOSE), THE RN CONNECTED THE NEEDLE TO THE HUB OF VACCINE AND PRIMED. THERE WERE NO APPARENT ISSUES WITH THE VACCINE DURING THIS ACTIVITY. AS THE RN ADMINISTERED THE INFLUENZA VACCINE, THE VACCINATION SQUIRTED OUT OF THE NEEDLE HUB AND RAN DOWN THE PATIENT'S SKIN. RN VISUALLY INSPECTED SET-UP, CONNECTIONS WERE APPROPRIATELY TIGHT. THERE WERE NO VISUAL DEFECTS WITH THE VACCINE OR NEEDLE. THIS WAS TWO EVENTS THAT HAPPENED BACK-TO-BACK IN THE CLINIC. THE CLINIC HAS REMOVED THIS PRODUCT FROM SUPPLY AND IS SWITCHING TO A DIFFERENT MANUFACTURER. THE PATIENTS NEEDED TO BE RE-VACCINATED. THERE WAS A PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20865118 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041399. One submission often covers many models, so check the product and lot details in each record.

• Z-1733-2019 · Feb 11, 2019 · Terminated
  Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration o
• Z-0897-2015 · Nov 21, 2014 · Completed
  Hypodermic Needle Pro Edge" Safety Device 20G x1; Reorder Number: 402010 Product Usage: The Needle Pro Edge Safety Hypodermic Needle is intended for injection or aspiration of flu
• Z-0898-2015 · Nov 21, 2014 · Completed
  Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 10mL Luer lock syringe; Reorder Number: 4102010 Product Usage: The Needle Pro Edge Safety Hypodermic Needle is intend
• Z-0899-2015 · Nov 21, 2014 · Completed
  Hypodermic Needle Pro Edge" Safety Device with Syringe 20G x1 5mL Luer lock syringe; Reorder Number: 452010 Product Usage: The Needle Pro Edge Safety Hypodermic Needle is intended