Monoject 8970YRecalls & reported problems
Cardinal Health 200, LLC · Monoject Sharps Container, Rotor Lid, Transparent Yellow, 2 Gallon · Class 2
All models of Monoject (35)
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 40884521018380), received between Mar 27, 2017 and May 11, 2021 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Crack1
- Difficult to Open or Close1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2021Break; Break
THE CUSTOMER REPORTED THERE WAS A BROKEN BOTTOM ON ONE OF THE SHARPS CONTAINERS RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11805982 ↗MalfunctionMay 8, 2019Difficult to Open or Close; Difficult to Open or Close
CUSTOMER REPORTS: DESPITE INSTRUCTIONS ON HOW TO LOCK THE CIRCULAR CLOSURE, THEY WERE UNABLE TO CLOSE THE CONTAINER.
Patient problems: No Patient Involvement
MAUDE report 8593193 ↗MalfunctionMar 27, 2017Crack; Crack
THE CUSTOMER STATES THE BOTTOM OF THE SHARPS CONTAINER BROKE WHEN THE NURSE WAS PREPARING TO REMOVE THE CONTAINER. BOTTOM BROKE OUT AND CONTENTS SPILLED OUT, CLIENTS IN ROOM NURSE MOVED THEM OUT OF THE ROOM SO THAT THERE WAS NO DANGER TO THEM. CONTAINER CONTAINED DIRTY SHARPS SO DISPOSED OF AS PER REGULAR PROCESS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6435726 ↗
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 8932PG2Cardinal Health, Inc. · 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 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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