Jelco 4288Recalls & reported problems
Icu Medical, Inc. · Class 2
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 20351688046809), received between Nov 13, 2018 and Sep 11, 2026 — classified as 16 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak9
- Leak/Splash4
- Break1
- Detachment of Device or Device Component1
- Fail-Safe Problem1
- Misconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Consequences Or Impact To Patient4
- Foreign Body In Patient1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 11, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741099 ↗MalfunctionSep 11, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741098 ↗MalfunctionSep 11, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741097 ↗MalfunctionSep 11, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741093 ↗MalfunctionSep 11, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50741090 ↗MalfunctionSep 2, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564937 ↗MalfunctionMar 30, 2026Fluid/Blood Leak; Detachment of Device or Device Component
IT WAS STATED DURING MEDICATION ADMINISTRATION, THE MEDICATION BEGAN LEAKING FROM THE NEEDLE HUB, AND ONLY HALF OF THE DOSE WAS INJECTED WHILE THE REMAINING MEDICATION LEAKED OUT. WHEN THE PROVIDER WITHDREW THE DEVICE, THE NEEDLE COMPLETELY DETACHED FROM THE SAFETY HUB AND REMAINED IN THE PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24713728 ↗MalfunctionMar 9, 2026
DEVICE MALFUNCTION - NEEDLE DETACHED IN PT'S ARM WHEN ADMINISTERING IM INJECTION WITH SMITHS MEDICAL HYPODERMIC NEEDLE PRO 22G X 1 1/2 INCH NEEDLE, THE NEEDLE DISCONNECTED FROM THE NEEDLE PROTECTION DEVICE. (AT THE GREY HUB, NOT LUERLOCK CONNECTION) AND STAYED IN PT'S ARM.
Patient problems: Foreign Body In Patient
MAUDE report 24549410 ↗MalfunctionAug 28, 2025Break; Misconnection; Break; Misconnection
IT WAS STATED THAT THE PRODUCT HAD THE CONNECTION BETWEEN THE HUB AND SYRINGE BREAK OFF. THE PATIENT WAS LEFT WITH THE NEEDLE IN THE ARM. IT WAS THEN REMOVED BY THE PATIENT AND THROWN THEN IT STRUCK. THE PATIENT DID HAVE KNOWN DISEASES. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT THE HOSPITAL. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS A PATIENT INVOLVEMENT AND CLINICIAN INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22916860 ↗MalfunctionMay 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE INJECTION LEAKED AT THE HUB WITH TWO DIFFERENT NEEDLES DURING THE PROCESS. THE THIRD ATTEMPT SUCCEEDED. THE PROCEDURE WAS COMPLETED AFTER APPLYING AND TESTING A THIRD NEEDLE ON THE SYRINGE. THE LEAKING WAS NOTED WHILE DRAWING UP MEDICATION INTO THE SYRINGE, PRIOR TO INJECTION. THE PATIENT¿S SKIN WAS NOT PUNCTURED UNTIL THERE WAS CONFIRMATION THAT THE NEEDLE WAS NOT LEAKING AT THE HUB AFTER ATTACHING THE 3RD NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22030228 ↗MalfunctionMay 13, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT "SPRAYS MEDS OUT OF NEEDLE". THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: Insufficient Information
MAUDE report 19299249 ↗MalfunctionJan 30, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE INJECTING PATIENT WITH MEDICATION, MEDICATION DID NOT DISPERSE INTO PATIENT JOINT, BUT INSTEAD CAME OUT OF THE SIDE OF THE NEEDLE. NEEDLE WAS CHECKED WITH SYRINGE TO ENSURE THAT IT WAS ON PROPERLY AND NEEDLE/SYRINGE LINED UP AND WAS AS TIGHT AS POSSIBLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11255623 ↗MalfunctionJan 30, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE INJECTING PATIENT WITH MEDICATION, MEDICATION DID NOT DISPERSE INTO PATIENT JOINT, BUT INSTEAD CAME OUT OF THE SIDE OF THE NEEDLE. NEEDLE WAS CHECKED WITH SYRINGE TO ENSURE THAT IT WAS ON PROPERLY AND NEEDLE/SYRINGE LINED UP AND WAS AS TIGHT AS POSSIBLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11255621 ↗MalfunctionJan 30, 2021Leak/Splash; Leak/Splash
2/4 REFERENCE (B)(4) FOR ALL THE RELATED COMPLAINTS AND ATTACHMENTS WHILE INJECTING PATIENT WITH MEDICATION, MEDICATION DID NOT DISPERSE INTO PATIENT JOINT, BUT INSTEAD CAME OUT OF THE SIDE OF THE NEEDLE. NEEDLE WAS CHECKED WITH SYRINGE TO ENSURE THAT IT WAS ON PROPERLY AND NEEDLE/SYRINGE LINED UP AND WAS AS TIGHT AS POSSIBLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11255619 ↗MalfunctionJan 30, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED THAT WHILE INJECTING PATIENT WITH MEDICATION, MEDICATION DID NOT DISPERSE INTO PATIENT JOINT, BUT INSTEAD CAME OUT OF THE SIDE OF THE NEEDLE. NEEDLE WAS CHECKED WITH SYRINGE TO ENSURE THAT IT WAS ON PROPERLY AND NEEDLE/SYRINGE LINED UP AND WAS AS TIGHT AS POSSIBLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11255618 ↗MalfunctionNov 13, 2018Fail-Safe Problem
HAVE BEEN HAVING REPEATED ISSUES WITH THIS SPECIFIC TYPE NEEDLE. THIS ONE THE SAFETY SNAPPED OFF (BARELY TOUCHED IT) BEFORE THE NEEDLE WAS USED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8068999 ↗
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 · TerminatedJelco, 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.
Other Needle, hypodermic, single lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.