Monoject 8881541067Recalls & reported problems
Cardinal Health, Inc. · True content to be populated as part of rebranding · 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 20884521106410), received between Jun 17, 2021 and Jun 17, 2021 — classified as 1 malfunction.
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
- Appropriate Device Problem Term/Code Not Available1
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.
MalfunctionJun 17, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE CUSTOMER REPORTS THAT WHILE DRAWING UP A MEDICATION FOR A SURGICAL CASE, A 6CC MONOJECT SYRINGE WITH AN ATTACHED NEON YELLOW BLUNT TIP WAS USED. AFTER PUNCTURING THE VIAL AND WITHDRAWING THE MEDICATION INTO THE SYRINGE, A SMALL PIECE OF RUBBER THAT WAS CORED OUT FROM THE VIAL STOPPER WAS NOTED TO BE FLOATING IN THE MEDICATION INSIDE OF THE SYRINGE. SINCE THE CONTAMINANT WAS NOTICED BEFORE PROVIDING CARE FOR THE CUSTOMER NO HARM OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12017808 ↗
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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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