Monoject 8881401064Recalls & reported problems
Cardinal Health, Inc. · Dental Needle,Metal Hub,27 G Short · Class 1
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 30884521002894), received between Mar 29, 2021 and Mar 29, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Connection 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Connection Problem1
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.
MalfunctionMar 29, 2021Connection Problem; Connection Problem
THE CUSTOMER REPORTED THAT THEY ARE HAVING ISSUES WITH THE NEEDLE ENGAGING, THEY JUST KEEP TURNING WHEN THEY ARE THREADING THEM. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11582069 ↗
Other NEEDLE, DENTAL devices
- Monoject 8881400074Cardinal Health, Inc. · NEEDLE, DENTAL5 reports
- Monoject 8881401072Cardinal Health, Inc. · NEEDLE, DENTAL4 reports
- Monoject 8881400058Cardinal Health, Inc. · NEEDLE, DENTAL3 reports
- Monoject 8881401056Cardinal Health, Inc. · NEEDLE, DENTAL3 reports
- Monoject 8881401171Cardinal Health, Inc. · NEEDLE, DENTAL1 report
- Monoject 8881401049Cardinal Health, Inc. · NEEDLE, DENTAL1 report
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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