Jelco 4291Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 20351688046816), received between Feb 9, 2017 and Sep 25, 2026 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (19 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 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902444 ↗
• MalfunctionApr 22, 2026Fluid/Blood Leak

  IT WAS STATED THAT THE NEEDLE FELL OFF DURING USE WITH A PATIENT. MULTIPLE SCENARIOS WERE REPORTED IN WHICH MEDICATION LEAKED OUT THE SIDE OF THE NEEDLE. STAFF ATTEMPTED TO ADMINISTER THE MEDICATION, BUT THE NEEDLE FELL OFF DURING THE PROCESS. IN ONE CASE, THE NEEDLE BECAME STUCK IN A PATIENT¿S ABDOMEN AFTER INJECTION. IN ANOTHER SCENARIO, A NURSE DREW UP MEDICATION, AND WHEN IT WAS REMOVED THE NEEDLE FROM THE VIAL, THE MEDICATION SPRAYED OUT AND HIT THE FACE. THE MEDICATION MOST COMMONLY INVOLVED WAS HEPARIN USED FOR SUBCUTANEOUS INJECTIONS. NO PATIENTS WERE HARMED IN ANY OF THE CASES. THERE WERE PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24952918 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLES WERE LEAKING WHEN USED FOR INJECTIONS. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND PATIENT HARM, IF ANY, IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977797 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLES WERE LEAKING WHEN USED FOR INJECTIONS. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND PATIENT HARM, IF ANY, IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977706 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLES WERE LEAKING WHEN USED FOR INJECTIONS. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND PATIENT HARM, IF ANY, IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977666 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLES WERE LEAKING WHEN USED FOR INJECTIONS. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND PATIENT HARM, IF ANY, IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977576 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLES WERE LEAKING WHEN USED FOR INJECTIONS. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND PATIENT HARM, IF ANY, IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977253 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLES WERE LEAKING WHEN USED FOR INJECTIONS. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND PATIENT HARM, IF ANY, IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977175 ↗
• MalfunctionJan 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE NEEDLES WERE LEAKING WHEN USED FOR INJECTIONS. THERE WAS NO REPORTED PATIENT INVOLVEMENT, AND PATIENT HARM, IF ANY, IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23977132 ↗
• MalfunctionJan 6, 2026Break

  IT WAS REPORTED THAT THE NEEDLE DISCONNECTED FROM THE PROTECTION DEVICE. A NURSE ADMINISTERED AN INJECTION USING THE NEEDLE. WHEN SHE WITHDREW IT, THE NEEDLE REMAINED IN THE PATIENT¿S SKIN. THE EVENT OCCURRED DURING PATIENT USE, WITH PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23976077 ↗
• MalfunctionDec 17, 2025Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem

  IT WAS REPORTED THAT ON REMOVING THE NEEDLE FROM THE PATIENT THE NEEDLE CAME AWAY FROM THE SAFETY MECHANISM REMAINING IN THE PATIENT. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED. PHOTOS ARE ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832416 ↗
• MalfunctionOct 30, 2025Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT, WHILE PERFORMING A SUBCUTANEOUS INJECTION FOR A PATIENT, THE USER NOTICED THAT THE SYRINGE WAS LEAKING SLIGHTLY FROM THE NEEDLE TOP. PER REPORTER, AFTER REMOVING THE NEEDLE FROM THE PATIENT, THE TOP PORTION OF THE NEEDLE REMAINED IN THE ARM AND WAS DETACHED FROM THE LUER-LOCK NEEDLE HOLDER AND NEEDLE PROTECTION DEVICE. REPORTER STATED THAT IT APPEARS THE TOP OF THE NEEDLE IS DETACHABLE FROM THE MAIN BODY OF THE NEEDLE AND NEEDS SECURING BEFORE UTILIZING. REPORTER STATED THEY SAFELY REMOVED THE NEEDLE FROM THE PATIENT'S ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23426901 ↗
• MalfunctionOct 21, 2025Break; Break

  IT WAS REPORTED THAT WHILE ATTEMPTING TO REMOVE THE NEEDLE AFTER USE, THE METAL PART DETACHED FROM ITS CASING AND REMAINED INSIDE THE PATIENT'S SKIN. THERE WAS UNKNOWN INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347250 ↗
• MalfunctionJul 16, 2025Premature Separation; Premature Separation

  IT WAS STATED THAT THE NEEDLE WOULD NOT SECURELY FIT ON THE SYRINGE. IT WAS DISCONNECTED DURING DRUG ADMINISTRATION. THE NEEDLE WAS LEFT IN PATIENT. THE DEVICE WAS HANDLED BY A HEALTHCARE PROFESSIONAL. THE DEVICE WAS WITHDRAWN FROM USE. THERE WAS PATIENT INVOLVEMENT. THE INCIDENT HAS BEEN REPORTED TO THE REGULATORY AGENCY. NCA REFERENCE NUMBER 2025/006/020/501/005 AND MHRA REFERENCE 35959506-AICXML. ASSOCIATED NEEDLE COMPLAINT DOCUMENTED ON CN-399210.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22525249 ↗
• MalfunctionJul 16, 2025Premature Separation; Premature Separation

  IT WAS STATED THAT THE NEEDLE WOULD NOT SECURELY FIT ON THE SYRINGE. IT WAS DISCONNECTED DURING DRUG ADMINISTRATION. PATIENT DID NOT RECEIVE THE FULL DOSE. THE DEVICE WAS HANDLED BY A HEALTHCARE PROFESSIONAL. THE DEVICE WAS WITHDRAWN FROM USE. THERE WAS PATIENT INVOLVEMENT. THE INCIDENT HAS BEEN REPORTED TO THE REGULATORY AGENCY. NCA REFERENCE NUMBER (B)(4) AND MHRA REFERENCE (B)(4). ASSOCIATED NEEDLE COMPLAINT DOCUMENTED ON (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22524967 ↗
• 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 22464236 ↗
• MalfunctionMar 10, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE NEEDLE WASN'T SECURED WHEN PREPPED FOR USE. THE NEEDLE CAN BE SCREWED BACK ON TO SECURE BUT WAS FREQUENTLY COMING LOOSE. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THIS RESULTED IN MULTIPLE STICKS FOR THE PATIENT DUE TO THE MEDICATION NOT ALL BEING ADMINISTERED TO THE PATIENT, OR THE NEEDLE STAYING IN THE PATIENT. THERE WERE TWO ADMINISTRATIONS FOR MEDICATIONS REQUIRED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21560247 ↗
• MalfunctionJan 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN WITHDRAWING THE NEEDLE FROM THE PATIENT; NEEDLE DISLODGED FROM THE SYRINGE AND REMAINED IN THE PATIENT'S ARM. PROVIDER NOTIFIED OF 2 LARGE DROPS OF VACCINE THAT "LEAKED OUT." NO REVACCINATION REQUIRED. THE NEEDLE WAS TAKEN OUT OF THE PATIENT'S ARM AND THROWN AWAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21151919 ↗
• MalfunctionDec 27, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT MEDICATION LEAKED OUT FROM THE BASE OF THE ORANGE NEEDLE ONTO THE PATIENT'S LEG. THERE WAS NO PATIENT HARM AND NO ADDITIONAL PATIENT DETAILS CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026574 ↗
• MalfunctionJul 17, 2024Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT WHILE SUBCUTANEOUS INJECTION TO A PATIENT MEDICATION LEAKED OUT OF THE CONNECTION POINT FOR THE NEEDLE PROTECTION DEVICE. THERE WAS PATIENT INVOLVEMENT AND NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19766801 ↗
• MalfunctionJul 2, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING VACCINES THE NEEDLE WAS LEAKING FROM WHERE IT WAS MOUNTED ONTO THE SYRINGE. THIS WAS VALIDATED BY WATER BEING DRAWN UP USING THE SAME NEEDLES AND THE SAME THING HAPPENED. IT DID NOT HAPPEN WITH OTHER SIZED NEEDLES. THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19655923 ↗
• MalfunctionAug 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE NEEDLES COME OUT OF THE BASE OF ORANGE CAP AFTER BEING INJECTED INTO PATIENT'S ARM. THE NEEDLE IS THEN STUCK IN PATIENT'S ARM. THE NEEDLE WAS REMOVED WITH NO PATIENT HARM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15312039 ↗
• MalfunctionJan 18, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT WHEN ASPIRATING THE SYRINGE, BUBBLES OF AIR WERE ASPIRATED. THE NEEDLE WAS WITHDRAWN FROM THE SKIN TO CHECK AND IT WAS OBSERVED THAT A FEW MLS OF AIR WERE NOW IN THE SYRINGE. IT WAS ALSO NOTICED NEEDLE DID APPEAR VERY FLEXIBLE AS IT WAS EXCESSIVELY BENDING WHEN THE SAFETY COVER WAS BEING APPLIED. NO OTHER INFORMATION KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13282853 ↗
• MalfunctionDec 22, 2020Material Separation; Material Separation

  INFORMATION RECEIVED A SMITHS MEDICAL SHARPS SAFETY/JELCO HYPODERMIC NEEDLE-PRO NEEDLE REPORTED INCIDENT OF " NEEDLE BROKE IN PATIENT'S ARM."

  Patient problems: Foreign Body In Patient

  MAUDE report 11059421 ↗
• MalfunctionNov 20, 2020Material Separation; Material Separation

  NEEDLE REMOVED FROM PATIENT WITH NO ADVERSE EFFECTS.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 10880353 ↗

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.