Monoject 1182705Recalls & reported problems
Cardinal Health, Inc. · Hypodermic Safety Needle · Class 2
All models of Monoject (164)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521544765), received between Mar 14, 2017 and Aug 24, 2023 — classified as 1 injury, 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.
Most reported problems
Device problems
- Fluid/Blood Leak2
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2023Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTS: ANOTHER HYPODERMIC SAFETY NEEDLE LEAKED FOR ONE OF OUR RNS IN THE NEWBORN NURSERY ON FRIDAY, AUGUST 18TH, WHEN SHE WAS PERFORMING A CIRCUMCISION ON A BABY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17618950 ↗MalfunctionAug 4, 2023Fluid/Blood Leak; Fluid/Blood Leak
CUSTOMER REPORTS: WE HAD AN ISSUE WHEN USING THE MONOJECT 27GA NEEDLE FOR LIDOCAINE FOR A CIRCUMCISION, IT LEAKED AROUND THE HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17465408 ↗InjuryMar 14, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER STATES THE NEEDLE IS DULL, IT IS HARD TO PUT THE NEEDLE NO THE SYRINGE AND THE NEEDLES FALLS OFF DURING INJECTION.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 6403707 ↗
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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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