Jelco 4292Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 20351688046854), received between Feb 29, 2016 and Aug 27, 2026 — classified as 44 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (20 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2026Fluid/Blood Leak

  It was reported that during injection with Jelco Hypodermic Needle-Pro Needles, the sharp detached from the needle body, as if not properly attached resulting in local anesthetic spraying back into the user's face. who was wearing appropriate Personal Protective Equipment (PPE) at the time of incident. There was patient involvement and no harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50485236 ↗
• MalfunctionAug 27, 2026Fluid/Blood Leak

  It was reported that during injection with Jelco Hypodermic Needle-Pro Needles, the sharp detached from the needle body, as if not properly attached resulting in local anesthetic spraying back into the user's face. who was wearing appropriate Personal Protective Equipment (PPE) at the time of incident. There was patient involvement and no harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50485203 ↗
• MalfunctionMay 11, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLE WAS LEAKING MEDICATION AT THE HUB. PATIENT INVOLVEMENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136744 ↗
• MalfunctionMay 11, 2026Fluid/Blood Leak

  IT WAS STATED THAT THE NEEDLE LEAKED MEDICATION FROM BASE OF THE PLASTIC. PATIENT INVOLVEMENT WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136717 ↗
• MalfunctionMay 8, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE THE PRODUCT WAS BEING USED FOR AN INJECTION, THE PRODUCT BROKE AWAY COMPLETELY DURING INJECTION ALONG WITH THE NEEDLE INTO THE PATIENT¿S ARM. THE CUSTOMER ADVISED THAT THE VACCINE LIQUID SUBSEQUENTLY DISCHARGED ONTO THE PATIENT AND THE EXAM TABLE. LEAKS THAT COULD POTENTIALLY EXPOSE PATIENT AND/OR CLINICIAN TO DRUG. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THERE WERE PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25125720 ↗
• MalfunctionFeb 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE CONNECTOR WAS NOT TIGHT AND CAUSED A LEAK OF MEDICATION IN ADDITION TO STAYING IN THE PATIENTS ARM WHEN ATTEMPTING TO PULL OUT THE NEEDLE. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261619 ↗
• MalfunctionDec 19, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE NEEDLE STAYED IN THE ARM OF THE PATIENT AFTER INJECTION. THERE WERE NO PATIENT HARM OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848977 ↗
• MalfunctionDec 19, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE NEEDLE CAME OFF THE HUB BEFORE INJECTION. THERE WERE NO PATIENT HARM OR ADVERSE EVENT REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23848942 ↗
• MalfunctionNov 4, 2025Break; Break

  IT WAS REPORTED THAT THE NEEDLE BROKE OFF IN PATIENT'S ARM DURING USE. PER REPORTER, THERE WAS PATIENT HARM. THE OUTCOME OF THE EVENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23464551 ↗
• MalfunctionNov 4, 2025Break; Break

  IT WAS REPORTED THAT THE NEEDLE BROKE OFF IN PATIENT'S ARM DURING USE. PER REPORTER, THERE WAS PATIENT HARM. THE OUTCOME OF THE EVENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23464532 ↗
• MalfunctionAug 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THEY CONNECTED THE NEEDLE TO A SYRINGE TO DRAW UP THE MEDICATION AND NOTICED THAT IT LEAKED FROM THE POINT WHERE THE NEEDLE JOINED THE SYRINGE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22706305 ↗
• MalfunctionJul 9, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLE WAS LEAKING MEDICINE FROM THE HUB AND NEEDLE WAS SEPARATED FROM THE HUB WHEN GIVING AN IMMUNIZATION. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22464218 ↗
• MalfunctionJun 19, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE NEEDLED DOES NOT SCREW ON THE SYRINGE PROPERLY, AND EVEN IF THEY WERE TIGHTLY SCREWED, SOLUTION STILL LEAKS. TWO INSTANCES WHEREIN THE HEALTHCARE PROFESSIONAL RETRACTED A SYRINGE AFTER AN INJECTION, THE NEEDLE DID NOT CAME OFF WITH THE SYRINGE, IT WAS STUCK ON THE PATIENT'S ARM. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294212 ↗
• MalfunctionMar 10, 2025Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  IT WAS REPORTED THAT THE NEEDLE POPPED OUT AND LEAKED WHEN THE VACCINE WAS ADMINISTERED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560250 ↗
• MalfunctionFeb 10, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE NEEDLE STAYED IN THE ARM OF THE PATIENT AFTER INJECTION. THERE WERE NO PATIENT HARM OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21343646 ↗
• MalfunctionFeb 6, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE NEEDLE CAME OFF THE HUB BEFORE INJECTION. THERE WERE NO PATIENT HARM OR ADVERSE EVENT REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21328225 ↗
• MalfunctionDec 6, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRODUCTS 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 20868875 ↗
• MalfunctionDec 6, 2024Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRODUCT IS 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 ARE 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 20868209 ↗
• MalfunctionNov 18, 2024Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING INJECTION, SOLUTION LEAKED AROUND NEEDLE CONNECTOR. UPON REMOVING THE SYRINGE, THE NEEDLE DISCONNECTED FROM THE HUB AND REMAINED IN THE PATIENT'S ARM. NEEDLE WAS REMOVED AND CAPPED WITHOUT INJURY TO STAFF. THE EVENT RESULTED IN NO PATIENT HARM. NO MEDICAL INTERVENTION REQUIRED. NO FURTHER CARE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20705723 ↗
• MalfunctionNov 4, 2024Break; Break

  IT WAS REPORTED THAT THE REGISTERED NURSE (RN) ADMINISTERED AN INTRAMUSCULAR INJECTION TO PATIENT'S RIGHT DELTOID. UPON WITHDRAWAL, THE NEEDLE WAS LEFT BEHIND IN THE PATIENT'S ARM AND THE SAFETY MECHANISM FAILED TO REMAIN INTACT. THE RN REMOVED THE NEEDLE, AND THE PATIENT JERKED. SUBSEQUENTLY, THE NEEDLE FELL OUT OF THE RN'S HAND, LEADING TO NEEDLE STICK. THE EVENT DID NOT RESULT IN PATIENT HARM. THE EVENT OCCURRED IN THE PATIENT'S ROOM DURING RN MEDICATION ADMINISTRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20598906 ↗
• MalfunctionOct 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE NEEDLE DETACHING FROM THE SAFETY HOUSING AND SYRINGE WHEN INJECTING. SPECIFICALLY, WHEN WITHDRAWING THE NEEDLE AFTER INJECTING, THE NEEDLE STAYS BEHIND. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452631 ↗
• MalfunctionSep 30, 2024Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE NEEDLES WERE NOT TIGHTENED AT THE HUB BEFORE IT WAS USED. THEY WERE SO LOOSE THAT THEY EASILY CAME OFF THE NEEDLE CONTRAPTION. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333995 ↗
• MalfunctionSep 3, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLES POPPED OFF DURING INJECTION AND TWO WERE LEAKING DURING INJECTION, WON'T HOLD OR STAY IN PLACE. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20126734 ↗
• MalfunctionAug 13, 2024Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLE POPPED OFF DURING THE INJECTION AND LEAKED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973855 ↗
• MalfunctionJul 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLES ARE COMING OFF WHEN THEY ARE GIVING INJECTIONS RESULTING IN THE NEEDLE REMAINING IN THE PATIENT'S ARM. THIS HAS OCCURRED WITH MULTIPLE PATIENTS INCLUDING PEDIATRIC PATIENTS OF BOTH SEXES. IT WAS STATED THE NEEDLES ARE GETTING STUCK IN PATIENTS INJECTION SITES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19776380 ↗

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.