Monoject 1180300555Recalls & reported problems
Cardinal Health 200, LLC · 3 mL Syringe Regular Tip · Class 2
All models of Monoject (35)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521012295), received between Oct 25, 2019 and Mar 18, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Crack” (4 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.
Most reported problems
Device problems
- Crack4
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 18, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE SYRINGE HAS A CRACK OR SCRATCH ON THE SIDE, WHICH CAUSED BLOOD TO LEAK FROM THE SYRINGE DURING USE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9847609 ↗MalfunctionNov 26, 2019Crack; Crack
THE CUSTOMER REPORTED THAT THEY FOUND CRACKED SYRINGES UPON OPENING THE BOX. NO PATIENT INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 9375613 ↗MalfunctionOct 29, 2019Crack; Crack
THE CUSTOMER REPORTED THAT THERE WERE SCRATCHES AND HOLES IN THE SYRINGE THAT MAKE BLOOD BUBBLE WHEN THEY PULL IT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9251544 ↗MalfunctionOct 25, 2019Crack; Crack
THE CUSTOMER REPORTED THAT ONE OF THEIR PHLEBOTOMIST NOTICED THE 3ML SYRINGE WAS CRACKED, RESULTING IN A REDRAW.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9238454 ↗
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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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