Monoject 8881112059Recalls & reported problems
Cardinal Health, Inc. · 12 mL Syringe,Regular Tip · Class 2
All models of Monoject (164)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521010871), received between Apr 8, 2020 and May 26, 2021 — classified as 3 malfunctions.
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
- Device Contamination with Chemical or Other Material1
- Missing Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 26, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
THE CUSTOMER REPORTED THE SYRINGE HAS INK ON THE INSIDE NEAR THE BOTTOM. AT FIRST IT LOOKED LIKE THE PLUNGER BUT IT IS INK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11888664 ↗MalfunctionMay 28, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
THE CUSTOMER REPORTED THAT DURING INSPECTION, THEY FOUND THAT THE DEVICES HAD MATERIAL WITH FLASH IN THE FLUID PATH.
Patient problems: No Patient Involvement
MAUDE report 10095926 ↗MalfunctionApr 8, 2020Missing Information; Missing Information
THE CUSTOMER REPORTED THAT SOME NUMBERS AND LINES ARE MISSING FROM THE SYRINGES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9940724 ↗
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