Magellan 8881811510Recalls & reported problems
Cardinal Health, Inc. · 1 mL Syringe with Hypodermic Safety Needle · Class 2
- 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 10884521005891), received between Apr 1, 2021 and Apr 1, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (1 report).
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
- Device Contamination with Chemical or Other Material1
- Fluid/Blood Leak1
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.
MalfunctionApr 1, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT A NEEDLE-SYRINGE MALFUNCTION HAS OCCURRED WHILE INJECTING THE VACCINE TO A PATIENT RESULTING IN THE PATIENT NOT RECEIVING THE FULL INTENDED AMOUNT OF THE VACCINE. THE LIQUID SPILLED ON PATIENT'S ARM ONLY. ONLY A VERY SMALL AMOUNT OF VACCINE REACHED THE PATIENT, EXACT AMOUNT IS UNKNOWN, LIKELY MORE THAN 90% AMOUNT WAS SPILLED. THE PATIENT WAS ACCOMPANIED BY THEIR MOTHER AND IS AWARE OF THE SITUATION. THE LVN TIGHTENED THE SYRINGE ATTACHMENT TO THE NEEDLE PRIOR TO DRAWING, AND AFTER DRAWING TO ENSURE THE INJECTION IS TIGHT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19012776 ↗MalfunctionApr 1, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE CUSTOMER REPORTED BEFORE OPENING THE PACKAGE THEY NOTICED THERE WAS SOMETHING ON THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11605581 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.