Monoject 8881513231 (UDI 20884521012711)Recalls & reported problems
Cardinal Health, Inc. · 3 mL Syringe with Standard Hypodermic Needle · 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 20884521012711), received between Sep 20, 2019 and Oct 12, 2023 — classified as 5 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
- Break1
- Device Markings/Labelling Problem1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 12, 2023Break; Break
THE CUSTOMER REPORTED THAT THEY HAVE ONE BOX OF LOT NUMBER 22L082 THAT HAD 15 DEFECTIVE SYRINGES IN IT. THE NEEDLE IS A DIFFERENT COLOR ON SOME AND THE CONNECTION BETWEEN SYRINGE AND NEEDLE IS CRACKED OR COMPLETELY GONE ON SOME OF THEM. PHOTOS WERE PROVIDED WHICH APPEAR TO SHOW BROKEN/CRACKED/MISSING LUER TIPS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17919748 ↗MalfunctionOct 12, 2023Physical Resistance/Sticking; Physical Resistance/Sticking
THE CUSTOMER REPORTED THAT IT HAS A BENT AND CAN'T PULL BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17919687 ↗MalfunctionMar 29, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED IT LOOKS LIKE THE RUBBER PLUNGERS MELTED OR SOMETHING. WHEN THEY TRIED TO PULL UP A VACCINE THE CONTENTS DRIPPED OUT OF THE PLUNGER SIDE OF THE SYRINGE. THEY KIND OF LOOKED FLIPPED TO THE SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16637657 ↗MalfunctionDec 16, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT ABOUT 1/3 OF THE BOX IS LEAKING THROUGH THE PLUNGER. THE PRODUCT WAS USED IN A VETERINARY SETTING. ADDITIONAL INFORMATION STATED THAT THE SYRINGE DOESN'T APPEAR TO HAVE ANY PROBLEMS. THE PLUNGER IS SEATED CORRECTLY. THE CUSTOMER ALSO STATED THERE IS NOT AN EXPIRATION DATE ON THE CARTON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16000232 ↗MalfunctionSep 20, 2019Device Markings/Labelling Problem; Device Markings/Labelling Problem
THE CUSTOMER REPORTED THAT THE CLINIC SAID SOME OF THE MARKINGS ARE MISSING OR VERY LIGHT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9098621 ↗
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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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