Monoject 8906Recalls & reported problems
Cardinal Health 200, LLC · Monoject™ Phlebotomy Sharps Container, Yellow, 1 Quart · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521023437), received between Sep 29, 2017 and Dec 5, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fail-Safe Problem” (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
- Fail-Safe Problem1
- Material Puncture/Hole1
Patient problems
- Needle Stick/Puncture1
- 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.
InjuryDec 5, 2017Material Puncture/Hole; Material Puncture/Hole
THE CUSTOMER REPORTS THAT A NURSE SUFFERED A NEEDLE STICK INJURY BECAUSE IT WAS PROTRUDING FROM THE SHARPS CONTAINER.
Patient problems: Needle Stick/Puncture
MAUDE report 7084601 ↗MalfunctionSep 29, 2017Fail-Safe Problem; Fail-Safe Problem
ACCORDING TO THE REPORTER, ON (B)(6) 2017, DURING USE, THE CONTAINER DID NOT CLOSE OPTIMALLY. THE SYSTEM UNSCREWED THE BUTTERFLY TO BARREL AND DID NOT WORK WELL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 6905284 ↗
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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