Monoject 1188818100Recalls & reported problems
Cardinal Health, Inc. · Standard Hypodermic Needle,Polypropylene Hub · 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 10884521007048), received between Apr 4, 2022 and Apr 4, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (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
- Incomplete or Inadequate Connection1
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.
MalfunctionApr 4, 2022Incomplete or Inadequate Connection; Incomplete or Inadequate Connection
THE CUSTOMER REPORTED THAT THE 18-GAUGE NEEDLES ARE SUPPOSED TO LOCK ONTO THE SYRINGES AND THEY DON¿T LOCK. THEY KEEP SPINNING WHEN THEY PUT THEM ONTO THE SYRINGE. PER ADDITIONAL INFORMATION RECEIVED ON 18MAR2022, THERE WASN¿T ANY HARM DONE. THEY USED A DIFFERENT NEEDLE THEY HAD PURCHASED PREVIOUSLY AND THERE WERE NO PROBLEMS. THE SYRINGE USED WAS A 3RD PARTY SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13998829 ↗
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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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