Monoject 1182210Recalls & reported problems
Cardinal Health, Inc. · Hypodermic Safety Needle · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521544642), received between Mar 15, 2024 and May 16, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Defective 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Component1
- Fluid/Blood Leak1
Patient problems
- Laceration(s)1
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2025Defective Component; Defective Component
THE CUSTOMER REPORTED THAT THE PATIENT WAS GIVEN A VACCINE. WHEN I WENT TO ACTIVATE THE NEEDLE SAFETY FEATURE,IT FELL OFF AND THE NEEDLE SCRAPED MY FINGER CAUSING A SMALL CUT.
Patient problems: Needle Stick/Puncture
MAUDE report 22035513 ↗MalfunctionMay 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE CUSTOMER REPORTED THAT A NURSE WAS USING A MONOJECT¿ HYPODERMIC SAFETY NEEDLE, GREEN, 21GA X 1IN TO PERFORM A VENIPUNCTURE. SHE ACTIVATED THE SAFETY SHIELD. UPON THE SHIELD CLICKING IN PLACE, A LARGE BLOOD SPRAY CAME FROM THE NEEDLE AND LANDED ON THE PATIENTS CHAIRSIDE TABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035483 ↗MalfunctionMar 15, 2024
PATIENT WAS GIVEN A VACCINE. WHEN I WENT TO ACTIVATE THE NEEDLE SAFETY FEATURE, IT FELL OFF AND THE NEEDLE SCRAPED MY FINGER CAUSING A SMALL CUT.
Patient problems: Laceration(s)
MAUDE report 18911917 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.