Monoject 8881513231 (UDI 20192253037781)Recalls & reported problems
Cardinal Health 200, LLC · 3 mL Syringe with Standard Hypodermic Needle · Class 2
All models of Monoject (35)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20192253037781), received between Jul 30, 2024 and Nov 7, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THEY ARE FROM A VETERINARY PRACTICE THAT HAS USED MONOJECT 3 ML X 22 G X 1" NEEDLE/SYRINGE COMBOS FOR YEARS. RECENTLY, THEY HAVE HAD ISSUES WITH THE SYRINGES BEING CRACKED. THE SYRINGES ARE IN THE PLASTIC HARD PACK AND SEEM UNDAMAGED. ONCE THE SYRINGE IS TAKEN OUT OF THE HARD PACK AND THE SYRINGE FILLED, IT BECOMES QUITE CLEAR THAT THERE IS A CRACK IN THE WALL OF THE SYRINGE AND THE PRODUCT THAT THEY HAVE TRIED TO FILL THE SYRINGE WITH LEAKS OUT. THEY HAVE WASTED QUITE A FEW DOSES OF VACCINES AND MOST RECENTLY A COSTLY BIOLOGICAL WAS WASTED. UNFORTUNATELY, SINCE THE EVENTS STARTED OUT RANDOMLY THERE WAS NOT A NOTATION OF THE BATCH OR LOT # THE SYRINGE CAME FROM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20633509 ↗MalfunctionJul 30, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT THE RUBBER IS FAULTY AND BLOOD IS GOING AROUND THE SEAL. ON (B)(6) 2024 THE INITIAL REPORTER STATED THAT SHE DOES NOT KNOW IF THE BLOOD LEAKED OUT OF THE SYRINGE BARREL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19867793 ↗
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