Monoject 31142222Recalls & reported problems
Cardinal Health, Inc. · Monoject Sharps Container Red, 2 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 40884521023100), received between Dec 23, 2020 and Jul 16, 2021 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break2
- Material Puncture/Hole2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 16, 2021Break; Break
THE CUSTOMER REPORTED THAT THE SHARPS CONTAINER WAS RECEIVED WITH THE LIP THAT THE LID LOCKS INTO BROKEN OFF. THERE WAS NO DAMAGE TO THE SHIPPING BOX.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12185382 ↗MalfunctionJul 16, 2021Break; Break
THE CUSTOMER REPORTED THAT THE SHARPS CONTAINER WAS RECEIVED WITH THE LIP THAT THE LID LOCKS INTO BROKEN OFF. THERE WAS NO DAMAGE TO THE SHIPPING BOX. THE PRODUCT WAS NOT USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12185328 ↗MalfunctionApr 20, 2021Material Puncture/Hole; Material Puncture/Hole
CUSTOMER REPORTS: THE 1ML TUBERCULIN SYRINGE POKED OUT OF THE SHARPS CONTAINER AFTER IT WAS AUTOCLAVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11693520 ↗MalfunctionDec 23, 2020Material Puncture/Hole; Material Puncture/Hole
THE CUSTOMER REPORTED THAT WHEN THE SHARPS CONTAINERS ARE AUTOCLAVED AT LEVEL 3, THE NEEDLES STICK OUT OF THE CONTAINER AFTERWARDS DUE TO PRESSURE. THERE WAS NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11066209 ↗
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 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
- 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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