Monoject 8980SRecalls & reported problems
Cardinal Health, Inc. · Monoject™ Sharps Container, Slide Lid, Red, 8 Gallon · Class 2
Data updated Oct 13, 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 30884521022489), received between Feb 28, 2020 and Aug 27, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Crack” (2 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Crack2
- Break1
- Component Incompatible1
- Difficult to Open or Close1
Patient problems
- No Consequences Or Impact To Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 27, 2020Break; Component Incompatible; Break; Component Incompatible
THE CUSTOMER REPORTED THE LID CANNOT BE ATTACHED AND PLASTIC PARTS BREAK OFF WHEN ATTEMPTING TO ATTACH IT. THE CUSTOMER ALSO REPORTED THE CAP THAT SEALS THE LID IS INSERTED THE WRONG WAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10462090 ↗MalfunctionJul 7, 2020Difficult to Open or Close; Difficult to Open or Close
THE CUSTOMER REPORTED THAT THEY CANNOT OPEN/CLOSE THE SLIDING LID OF THE SHARPS CONTAINER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10242566 ↗MalfunctionFeb 28, 2020Crack; Crack
THE CUSTOMER REPORTED THAT THERE WAS A CRACK ON THE LID AND BODY OF THE SHARPS CONTAINER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9771532 ↗MalfunctionFeb 28, 2020Crack; Crack
THE CUSTOMER REPORTED THAT THERE WAS A CRACK ON THE LID AND BODY OF THE SHARPS CONTAINER.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9771524 ↗
Other Container, sharps devices
- SharpSafety 8556HCardinal Health, Inc. · Container, Sharps65 reports
- Monoject 8507SACardinal Health, Inc. · Container, sharps13 reports
- BD Recykleen™ Sharps Collector 305160Becton, Dickinson And Company · Container, sharps6 reports
- Monoject 31142222Cardinal Health, Inc. · Container, sharps4 reports
- Monoject 8506YCardinal Health, Inc. · Container, sharps4 reports
- Monoject 8970YCardinal Health 200, LLC · Container, Sharps3 reports
- Monoject 85221RCardinal Health, Inc. · Container, sharps3 reports
- Monoject 8932PG2Cardinal Health, Inc. · Container, sharps3 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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