Monoject 8881560224Recalls & reported problems
Cardinal Health, Inc. · 60 mL Syringe Regular Tip · Class 2
All models of Monoject (164)
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 20884521012261), received between May 12, 2020 and Apr 18, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Crack1
- Fluid/Blood Leak1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 18, 2023Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
CUSTOMER REPORTS: THEY SYRINGE LEAKS FROM BOTH ENDS LIKE THEY ARE NOT SEALING PROPERLY WITH THE PLUNGER INSERTED. THEY TRIED ABOUT HALF OF THE BOX AND EVERY SYRINGE IS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16764697 ↗MalfunctionMay 12, 2020Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT THE TIPS OF THE SYRINGES WERE BENT. THE ISSUE WAS DISCOVERED PRIOR TO USE.
Patient problems: No Patient Involvement
MAUDE report 10049340 ↗
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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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