Monoject 8881535796Recalls & reported problems
Cardinal Health, Inc. · 35 mL Syringe Regular Tip · Class 2
All models of Monoject (164)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20884521012223), received between Jun 25, 2021 and Jun 25, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Imprecision” (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
- Imprecision1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 25, 2021Imprecision; Imprecision
THE CUSTOMER REPORTED THAT THEIR STAFF FOUND INACCURATE MARKINGS ON 35 ML SYRINGE. PER CUSTOMER, IT LOOKS LIKE THE STAMP WAS LINED UP INCORRECTLY WITH THE BOTTOM OF THE PLUNGER INSTEAD OF AT THE TOP AND THIS IS AN ISSUE WITH BEING UNABLE TO MEASURE MEDICATIONS ACCURATELY. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12067180 ↗
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- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
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- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 reports
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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