Monoject 8935YRecalls & reported problems
Cardinal Health, Inc. · Monoject Sharps Container, Slide Lid, Yellow, 12 Gallon · Class 2
Data updated Oct 13, 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 50884521022421), received between Sep 12, 2018 and Dec 31, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Open or Close” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Difficult to Open or Close1
- Fracture1
Patient problems
- No Consequences Or Impact To Patient1
- 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.
MalfunctionDec 31, 2019Difficult to Open or Close; Difficult to Open or Close
THE CUSTOMER REPORTED THAT THE SHARP COLLECTOR WAS NOT CLOSING PROPERLY. THE TRANSPARENT TOP WOULD NOT SNAP ON THE BOTTOM OF THE RED LINE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9535093 ↗MalfunctionSep 12, 2018Fracture; Fracture
THE CUSTOMER STATES THE CONTAINERS WERE FOUND CRACKED WHEN THE CARTON WAS OPENED.
Patient problems: No Patient Involvement
MAUDE report 7869936 ↗
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 8980SCardinal Health, Inc. · Container, sharps4 reports
- Monoject 8970YCardinal Health 200, LLC · Container, Sharps3 reports
- Monoject 85221RCardinal 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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