Magellan 8881833558 (UDI 10192253024760)Recalls & reported problems
Cardinal Health 200, LLC · 3 mL Syringe with Hypodermic Safety Needle 25G x 5/8" (0.5 x 16 mm) · Class 2
All models of Magellan (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10192253024760), received between Jun 19, 2024 and Jul 1, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE RN WAS ADMINISTERING SUBCUTANEOUS HEPARIN WITH A CARDINAL HEALTH MONOJECT MAGELLAN 3ML 25GX5/8" NEEDLE. THE RN PULLED UP HEPARIN WITH NO ISSUE. AFTER INJECTING THE NEEDLE INTO THE PATIENT, WHILE PUSHING ON THE PLUNGER TO INJECT THE MEDICATION, THE SYRINGE BECAME DISCONNECTED FROM THE NEEDLE, CAUSING HEPARIN TO EXPLODE ALL OVER RATHER THAN INJECTED INTO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19644913 ↗MalfunctionJun 19, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED A CRACK WAS DISCOVERED WHEN VACCINE LEAKED FROM THE SYRINGE DURING VACCINE PREPARATION. VACCINE WAS PROPERTY DISPOSED OF AND DISCARDED IN APPROPRIATE BIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19567497 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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