Monoject 8881112015Recalls & reported problems
Cardinal Health, Inc. · 12 mL Enteral Syringe · 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 10884521545465), received between Dec 12, 2019 and Dec 12, 2019 — 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 Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2019Imprecision; Imprecision
AS PER THE CUSTOMER, THE SYRINGE SHOWS INACCURATE MEASUREMENT. THE TOP GRADUATION MARK WAS SHIFTED DOWN WITH ABOUT 0.2ML. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Patient Involvement
MAUDE report 9458497 ↗
Other Enteral Syringes with enteral specific connectors devices
- Cardinal Health 1mlJiangsu Caina Medical Co.,Ltd · Enteral Syringes With Enteral Specific Connectors1 recall5 reports
- Cardinal Health 60mlJiangsu Caina Medical Co.,Ltd · Enteral Syringes With Enteral Specific Connectors1 recall4 reports
- Cardinal Health 35mlJiangsu Caina Medical Co.,Ltd · Enteral Syringes With Enteral Specific Connectors1 recall4 reports
- Cardinal Health 12mlJiangsu Caina Medical Co.,Ltd · Enteral Syringes With Enteral Specific Connectors1 recall0 reports
- Cardinal Health 6mlJiangsu Caina Medical Co.,Ltd · Enteral Syringes With Enteral Specific Connectors1 recall0 reports
- Cardinal Health 3mlJiangsu Caina Medical Co.,Ltd · Enteral Syringes With Enteral Specific Connectors1 recall0 reports
- Medline NON66160Medline Industries, Inc. · Enteral Syringes with enteral specific connectors4 reports
- ENFit Syringe PNM-S60NCAvanos Medical, Inc. · Enteral Syringes with enteral specific connectors3 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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