Monoject 8881401049Recalls & reported problems
Cardinal Health, Inc. · Dental Needle,Metal Hub,25 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 10884521002807), received between Jul 27, 2017 and Jul 27, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2017Leak/Splash; Leak/Splash
THE CUSTOMER STATED THAT THERE IS A TREMENDOUS AMOUNT OF LEAKAGE AND THE NEEDLE BROKE DURING A PROCEDURE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6748138 ↗
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 8881401064Cardinal 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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