Monoject 8881535762Recalls & reported problems
Cardinal Health, Inc. · 35 mL Syringe Luer-Lock Tip · Class 2
All models of Monoject (164)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20884521012193), received between Oct 25, 2018 and Jul 27, 2021 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Contamination” (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
- Contamination1
- Device Markings/Labelling Problem1
- Imprecision1
- Material Fragmentation1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
THE CUSTOMER REPORTED ONE OF THE SYRINGES LOOKED TO BE PARTIALLY MELTED AND THE MARKINGS WERE OFF. ADDITIONAL INFORMATION RECEIVED STATED THE MARKINGS WERE MISPRINTED ABOUT 5 ML OFF FROM THE ZERO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12233165 ↗MalfunctionJul 21, 2021Nonstandard Device; Nonstandard Device
THE CUSTOMER REPORTED THE MARKINGS ON THE SYRINGE ARE MISALIGNED AND CANNOT MEASURE VOLUME PROPERLY. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12206617 ↗MalfunctionJun 30, 2021Imprecision; Imprecision
THE CUSTOMER REPORTED THAT THE MARKINGS ON THE SYRINGE ARE WRONG AND POTENTIALLY RESULTING IN A DRAW UP OF MORE FLUID THAN NEEDED. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12094724 ↗MalfunctionSep 12, 2019Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT THE PLUNGERS WERE BROKEN. THE PLASTIC PIECES WERE INSIDE OF THE SYRINGE NEAR THE BLACK RUBBER PLUNGER TIP. THIS WAS DISCOVERED WHEN THE CUSTOMER OPENED THE PACKAGE.
Patient problems: No Patient Involvement
MAUDE report 9006351 ↗MalfunctionOct 25, 2018Contamination; Contamination
THE CUSTOMER REPORTS: THE BUNG HAS BLACK BITS CAUGHT DOWN THE SIDE. LOOKS LIKE RUBBER IS SPLITTING AWAY AND THE OTHER ISSUE WAS THE PLUNGER IS NOTICEABLY DAMAGED AND BENT INSIDE THE BARREL.
Patient problems: No Patient Involvement
MAUDE report 8006433 ↗
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