Monoject 8997SRecalls & reported problems
Cardinal Health, Inc. · Monoject Sharps Container, Gasketed Slide Lid, Red, 8 Gallon · Class 2
All models of Monoject (164)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30884521022526), received between Dec 30, 2020 and Dec 30, 2020 — classified as 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Difficult to Open or Close1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2020Difficult to Open or Close; Difficult to Open or Close
THE CUSTOMER REPORTED THAT THE LID DOES NOT FIT WELL. THERE WAS NO PATIENT OR STAFF HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11095671 ↗
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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