Monoject 8881250305Recalls & 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 20884521013817), received between Feb 5, 2021 and Apr 20, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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
- Detachment of Device or Device Component1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 20, 2021Fluid/Blood Leak; Fluid/Blood Leak
ADDITIONAL INFORMATION PROVIDED: NEITHER THE PATIENT NOR THE VACCINATOR WAS INJURED, BUT THE NURSE WAS INJURED (DERMABRASION) WHEN SHE HAD TO UNHOOK THE NEEDLE FROM ITS PLASTIC CAP (VERY HARD TO DO) DURING OTHER MANIPULATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions; Skin Inflammation/ Irritation
MAUDE report 11697196 ↗MalfunctionFeb 5, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED AFTER ATTACHING THE NEEDLE TO THE SYRINGE THE NEEDLE DISCONNECTS FROM THE SYRINGE. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11287821 ↗
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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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