Monoject 11812558 (UDI 10884521544819)Recalls & reported problems
Cardinal Health, Inc. · 1 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 10884521544819), received between Nov 20, 2019 and Jun 21, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Disconnection” (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
- Disconnection1
- Fail-Safe Did Not Operate1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 21, 2022Fail-Safe Did Not Operate
THE CUSTOMER REPORTED THAT WHEN HE WAS PLACING A TB SKIN TEST AND HAD ENGAGED THE SAFETY WHICH PUTS A COVER OVER THE TOP PORTION. PER CUSTOMER, HE WENT TO PUT THE CAP ON TO DISCARD AND NOTICED THAT THE SAFETY DISENGAGED. HE WAS ABLE REPLCATE IT WITH 2 OTHER NEEDLES,THE SAFETY DISENGAGES WITH LIGHT PRESSURE.THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14762594 ↗MalfunctionNov 20, 2019Disconnection; Disconnection
THE CUSTOMER REPORTED THAT WHEN ADMINISTERING HEP B INJECTION IM TO A NEWBORN, THE SYRINGE POPPED OFF THE NEEDLE WHILE THE NEEDLE WAS INSERTED INTO THE MUSCLE. THE NEEDLE AND HUB WERE SEPARATED WHEN THE NEEDLE WAS INSERTED INTRAMUSCULARLY. THERE WAS NO MEDICAL INTERVENTION REQUIRED OTHER THAN AN REPEATED INJECTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9350144 ↗
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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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