Monoject 8881106010Recalls & reported problems
Cardinal Health, Inc. · 6 mL Syringe,Luer-Lock Tip · Class 2
All models of Monoject (164)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521013889), received between May 21, 2020 and Sep 8, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Detachment of Device or Device Component1
- Device Contaminated During Manufacture or Shipping1
- Difficult to Advance1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2022Difficult to Advance; Physical Resistance/Sticking; Difficult to Advance; Physical Resistance/Sticking
CUSTOMER REPORTS: THE PLUNGER DOESN¿T MOVE AND CANNOT DRAW VOLUME INTO SYRINGE. ON 07SEP2022 THE SALES REP PROVIDED ADDITIONAL INFORMATION STATING THE CUSTOMER CONFIRMED THAT IT IS WAS THE PLUNGER THAT IS BROKEN, NOT THE PUMP. THE CUSTOMER FURTHER STATED THAT THEY PACKAGE THE SYRINGES INTO A CUSTOM KIT AND THEN STERILIZE THEM WHICH MEANS THEY ARE UNABLE TO TRACE BACK TO THE EXACT MATERIAL LOT SINCE ALL OF THE OCCURRENCES WERE FROM A KIT. THERE WAS NO REPORTED PATIENT IMPACTS. BASED ON THE ADDITIONAL INFORMATION RECEIVED THERE ARE SEVERAL POTENTIAL AFFECTED LOTS. LOT NUMBERS: 203978X, 131271X, 203978X, 201825X ,203977X, 131276X, 201826X, 100457X, 131270X, 128444X, 201826X, 128443X ARE ALL POTENTIAL LOT NUMBERS. THE TRUE AFFECTED LOT NUMBER(S) IS NOT KNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15379790 ↗MalfunctionJul 17, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
THE CUSTOMER REPORTED THAT A PARTICULATE AND HAIRS WERE FOUND IN THE 6 ML NON STERILE SYRINGES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10289787 ↗MalfunctionMay 21, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE TIP OF THE LUER WAS BROKEN AND DETACHED FROM THE SYRINGE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10078810 ↗
Other Syringe, piston devices
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- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- 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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