Monoject 8881412012Recalls & reported problems
Cardinal Health, Inc. · Curved Tip Syringes,12 mL · 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 10884521002494), received between Jan 20, 2020 and Jun 24, 2020 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material1
- Nonstandard Device1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2020Nonstandard Device; Nonstandard Device
THE CUSTOMER REPORTED THAT THEY TRIED TO USE THE PRODUCT BUT THE LIQUID CAN BACK OUT OF IT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10192380 ↗MalfunctionJan 20, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE CUSTOMER REPORTED THE DEVICE SEEMED TO HAVE A CONDENSATION OR A FILM LAYER INSIDE THE SYRINGE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9608692 ↗
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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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