Monoject 1188830340Recalls & 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521007475), received between Aug 12, 2019 and Mar 15, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2024
NEEDLE BECAME DISLODGED WHEN SECURED TO SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18912147 ↗InjuryAug 12, 2019Break; Break
THE CUSTOMER STATES THE DOCTOR REPORTED DURING THE APPLICATION OF BOTOX, SHE PULLED BACK THE SYRINGE AND NOTED THAT THE NEEDLE HAD BROKEN OFF THE HUB. THE DOCTOR WAS ABLE TO PULL THE NEEDLE OUT OF THE SKIN WITHOUT COMPLICATION AND CONTINUED THE TREATMENT. THE PATIENT LEFT WITHOUT COMPLICATIONS OR COMPLAINTS NOTED AFTER THE PROCEDURE.
Patient problems: Foreign Body In Patient
MAUDE report 8883895 ↗
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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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