Monoject 1180327114ERecalls & reported problems
Cardinal Health, Inc. · Endodontic Irrigation Syringe with Needle · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521195547), received between May 7, 2018 and May 7, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 7, 2018Break; Break
THE CUSTOMER STATES THE MONOJECT NEEDLE FRACTURED FROM THE BASE OF THE NEEDLE IN A PATIENTS MOUTH.
Patient problems: Foreign Body In Patient
MAUDE report 7491440 ↗
Other SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING devices
- VDW Eddy Flexcanula 21419Produits dentaires S.A. · Syringe, Periodontic, Endodontic, Irrigating55 reports
- Maxi-probe Irrigation Needle MAXP301TTulsa Dental Products LLC · SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING9 reports
- Henry Schein 5701403Henry Schein, Inc. · SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING1 report
- Henry Schein 5701401Henry Schein, Inc. · SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING1 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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