Monoject 1188825112Recalls & reported problems
Cardinal Health, Inc. · Standard Hypodermic Needle,Polypropylene Hub · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521007383), received between May 6, 2020 and Dec 4, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fitting 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.
Reports received per month
Most reported problems
Device problems
- Fitting Problem1
- Fluid/Blood Leak1
Patient problems
- Foreign Body In Patient1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THE NEEDLES DON'T HAVE A SNUG FIT ON THE SYRINGES. THE DOCTOR WENT TO INJECT, AND THE FLUID SPLASHED HIM IN THE EYES. THE CUSTOMER STATED IT IS NOT JUST THE NEEDLE REPORTED BUT OTHER SIZES AS WELL HOWEVER NO OTHER INFORMATION WAS PROVIDED OR ABLE TO BE OBTAINED.
Patient problems: Foreign Body In Patient
MAUDE report 20846864 ↗MalfunctionMay 6, 2020Fitting Problem; Fitting Problem
THE CUSTOMER REPORTED THAT THE NEEDLE DO NOT THREAD AND ARE OFTEN STRIPPED. THE CUSTOMER FURTHER STATED THAT, THERE WAS A CONNECTION ISSUE WITH THE LUER OF THE NEEDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10029170 ↗
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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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