Monoject 8881511310Recalls & reported problems
Cardinal Health, Inc. · 1 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884521014999), received between Feb 3, 2020 and Apr 13, 2020 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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
- Detachment of Device or Device Component2
- Break1
- Fail-Safe Did Not Operate1
Patient problems
- No Consequences Or Impact To Patient3
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE NEEDLE FELL OFF OF THE INSULIN SYRINGE DURING THE REMOVAL OF MEDICATION FROM THE VIAL.
Patient problems: No Patient Involvement
MAUDE report 9955205 ↗MalfunctionMar 2, 2020Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
THE CUSTOMER REPORTED THAT HE HAD A FAULTY INSULIN SYRINGE WHERE THE MECHANISM WOULD NOT LOCK AFTER HE USED THE SYRINGE. HE TRIED MULTIPLE TIMES BUT THE LOCKING MECHANISM WOULD NOT ENGAGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9774761 ↗MalfunctionFeb 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER STATED THAT THE NEEDLE BECAME STUCK IN THE MEDICATION VIAL RUBBER STOPPER AND IT WAS CLEANLY DETACHED FROM THE HUB. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9662158 ↗MalfunctionFeb 3, 2020Break; Break
THE CUSTOMER REPORTED THAT THE SAFETY SHIELD WHICH ENCOMPASS THE NEEDLE WAS CRACKED. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9661024 ↗
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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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