Monoject 8881511235Recalls & reported problems
Cardinal Health, Inc. · 1 mL Tuberculin Safety Syringe with Needle · Class 2
All models of Monoject (164)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20884521014975), received between Jul 2, 2020 and Aug 10, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination 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
- Contamination /Decontamination Problem1
- Nonstandard Device1
Patient problems
- Needle Stick/Puncture1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 10, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
THE CUSTOMER STATED THAT THERE IS A SUBSTANCE OR DEBRIS INSIDE THE NEEDLE/SYRINGE. THE CUSTOMER STATED THIS ISSUE WAS IDENTIFIED PRIOR TO USE.
Patient problems: No Patient Involvement
MAUDE report 10386024 ↗InjuryJul 2, 2020Nonstandard Device; Nonstandard Device
THE CUSTOMER STATED THERE WERE TWO NEEDLES INSIDE THE SAFETY DEVICE, ONE WAS POINTED IN THE OPPOSITE DIRECTION AND WAS NOT SEEN UNTIL THE SAFETY SHIELD WAS ENGAGED. WHEN THE SAFETY SHIELD WAS ENGAGED AFTER USE, ONE OF THE NEEDLES STUCK THE HEALTH CARE PROVIDER.
Patient problems: Needle Stick/Puncture
MAUDE report 10227499 ↗
Other Syringe, piston devices
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 reports
- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 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.
How reports and recalls are matched · Editorial policy · Report an error on this page