Monoject 11832310 (UDI 10884521544567)Recalls & reported problems
Cardinal Health, Inc. · 3 mL Syringe with Hypodermic Safety Needle · 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 10884521544567), received between May 30, 2023 and May 16, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Decoupling” (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
- Decoupling1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Needle Stick/Puncture1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 16, 2025Decoupling; Decoupling
CUSTOMER REPORTED THAT WHILE GIVING ATIVAN, THE NEEDLE CAME LOOSE FROM THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035466 ↗MalfunctionMay 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 23, THE NEEDLE FELL OFF FOLLOWING THE INJECTION AND EMPLOYEE ATTEMPTED TO GRAB IT. IT DID NOT NEED REMOVED FROM THE PATIENT. PREVIOUSLY, IT WAS REPORTED THAT THERE WAS NO NEEDLE STICK, HOWEVER IT HAS BEEN COMMUNICATED THAT ONE CONTAMINATED NEEDLE STICK DID OCCUR WITH A STAFF MEMBER.
Patient problems: Needle Stick/Puncture; No Clinical Signs, Symptoms or Conditions
MAUDE report 17024967 ↗
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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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