Monoject 8881511144Recalls & reported problems
Cardinal Health, Inc. · 3/10 mL Insulin Safety Syringe Permanent 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 20884521014951), received between Jan 9, 2020 and Nov 22, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fail-Safe Problem” (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
- Fail-Safe Problem1
- Illegible Information1
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.
MalfunctionNov 22, 2023Fail-Safe Problem; Fail-Safe Problem
THE CUSTOMER REPORTED THE INSULIN SYRINGE'S NEEDLE IS TRAPPED IN THE SAFETY DEVICE. THEY WERE UNABLE TO USE THE DEVICE. THE NEEDLE COULD CAUSE A SHARP INJURY IF THE SAFETY DEVICE IS ACTIVATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18191635 ↗MalfunctionJan 9, 2020Illegible Information; Illegible Information
THE INVESTIGATION FINDINGS DETERMINED THAT THE SYRINGE WAS MISSING GRADUATION LINES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9569142 ↗
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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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