Monoject 85221RRecalls & reported problems
Cardinal Health, Inc. · Monoject In-Room Sharps Container, Always-Open Lid, Transparent Red, 3 Gallon · Class 2
All models of Monoject (164)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521023369), received between Dec 16, 2019 and Nov 19, 2020 — classified as 3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Crack2
- Break1
Patient problems
- No Patient Involvement2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2020Break; Break
THE MANUFACTURING SITE PERFORMED A VISUAL INSPECTION OF THE SAMPLE RECEIVED ON (B)(6) 2020. DURING THEIR EVALUATION, THE INVESTIGATOR OBSERVED THAT THE LID WAS CRACKED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10867922 ↗MalfunctionSep 28, 2020Crack; Crack
A VIDEO WAS PROVIDED BY THE CUSTOMER AND UPON REVIEWING THE VIDEO, IT WAS NOTICED THAT THE CUSTOMER WAS REMOVING THE LID FROM THE CONTAINER AND THE LID CRACKED. THIS WAS NOTICED PRIOR TO USE AND NO PATIENT WAS INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 10597457 ↗MalfunctionDec 16, 2019Crack; Crack
THE CUSTOMER REPORTED THAT THE CASE OF RED CONTAINERS 3 OUT OF 10 SAFETY LIDS ARE CRACKED AND NOT SAFE TO USE. NO DAMAGE TO THE OUTSIDE OF CASE.
Patient problems: No Patient Involvement
MAUDE report 9475660 ↗
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 8980SCardinal Health, Inc. · Container, sharps4 reports
- Monoject 8506YCardinal Health, Inc. · Container, sharps4 reports
- Monoject 31142222Cardinal Health, Inc. · Container, sharps4 reports
- Monoject 8970YCardinal Health 200, LLC · 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 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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