Monoject 8881114063Recalls & reported problems
Cardinal Health, Inc. · True content to be populated as part of rebranding · 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 20884521128917), received between Mar 26, 2020 and Apr 4, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (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
- Air/Gas in Device1
- Unintended System Motion1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2022Air/Gas in Device; Air/Gas in Device
THE CUSTOMER REPORTED THAT THERE WAS AIR IN THE LINE. THE CUSTOMER REPORTED THAT DURING MORNING QC, AIR WAS CONSISTENTLY BEING PULLED INTO THE PUMP SYRINGE UPON REFILLING IT. THE CUSTOMER DID NOT NOTICE ANYTHING OUT OF THE ORDINARY TO CAUSE AIR IN THE PUMP SYRINGE. PER ADDITIONAL INFORMATION RECEIVED, AFTER SWAPPING OUT THE ACCESSORY PACKAGE WITH A NEW ONE, EVERYTHING WAS FUNCTIONING NORMALLY AGAIN. THERE WAS NO MEDICAL INTERVENTION GIVEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13996913 ↗MalfunctionMar 26, 2020Unintended System Motion; Unintended System Motion
THE CUSTOMER REPORTED THAT THE SYRINGE'S PLUNGER/PISTON CONTINUES TO FALL DOWNWARD AFTER SAMPLING. THE PLUNGER SEEMS TO BE MUCH LOOSER WHEN COMPARED TO OTHER SYRINGES. THERE WAS NO PATIENT HARM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9882544 ↗
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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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