Monoject 8881160629Recalls & reported problems
Cardinal Health, Inc. · 60 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
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521010963), received between Jul 15, 2019 and Jun 11, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Reports received per month
Most reported problems
Device problems
- Break3
- Material Deformation1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2024Break; Break
THE CUSTOMER REPORTED 60 ML SYRINGES DAMAGED. THE CUSTOMER PROVIDED PHOTOS THAT SHOW BROKEN LUER TIPS AND BROKEN SYRINGE BARRELS. NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19515228 ↗MalfunctionJun 11, 2024Break; Break
THE CUSTOMER REPORTED 60 ML SYRINGES DAMAGED. THE CUSTOMER PROVIDED PHOTOS THAT SHOW BROKEN LUER TIPS AND BROKEN SYRINGE BARRELS. NO FURTHER INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19515226 ↗MalfunctionDec 6, 2021Material Deformation; Material Deformation
THE CUSTOMER REPORTED THAT ONE SYRINGE HAD A SKEWED/SLANTED TIP AND THREADS. THE DEFINITIVE LOT NUMBER COULD NOT BE DETERMINED, BUT IT IS EITHER 916879X OR 011187X.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12935054 ↗MalfunctionAug 26, 2020Break; Break
THE CUSTOMER REPORTED 1 UNIT HAS A BROKEN SYRINGE TIP.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10454380 ↗MalfunctionJul 15, 2019Nonstandard Device; Nonstandard Device
THE CUSTOMER REPORTS ISSUES WITH NICKS/DAMAGE AND BUBBLES NEAR THE LUER TIP.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8790534 ↗
Other Syringe, piston devices
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page