Monoject 8881305117Recalls & reported problems
Cardinal Health, Inc. · Filter 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521012622), received between Apr 25, 2017 and Apr 25, 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 Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2017Leak/Splash; Leak/Splash
THE CUSTOMER STATES THAT THE 81-305117 18G NEEDLE DOES NOT WORK PROPERLY. IT DOES NOT RETRACT ANY FLUID INTO THE SYRINGE AND APPEARS AS IF IT HAS AN AIR LEAK.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6519930 ↗
Other NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE devices
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- N/A 305200Becton, Dickinson And Company · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE99 reports
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- TPAK TM-303TyTek Medical Inc. · Needle, Aspiration And Injection, Disposable1 recall0 reports
- N/A 305181Becton, Dickinson And Company · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE32 reports
- SOL-M™ Blunt Fill Needle with 5 Micron Filter 110022Sol-Millennium Medical, Inc. · Needle, Aspiration And Injection, Disposable17 reports
- CONFIDENCE SPINAL CEMENT SYSTEM 283903611Medos International Sàrl · NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE17 reports
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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