Monoject 11812558 (UDI 10192253025132)Recalls & reported problems
Cardinal Health 200, LLC · 1 mL Syringe with Hypodermic Safety Needle · Class 2
Data updated Oct 13, 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 10192253025132), received between May 19, 2022 and Jan 27, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Decoupling” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Decoupling1
- Defective Component1
- Fail-Safe Did Not Operate1
Patient problems
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 27, 2026Decoupling; Defective Component
THE CUSTOMER REPORTED AN INCIDENT WITH A CARDINAL SYRINGE COMING APART AND CAUSING A NEEDLE STICK.
Patient problems: Needle Stick/Puncture
MAUDE report 24186397 ↗MalfunctionMay 19, 2022Fail-Safe Did Not Operate; Fail-Safe Did Not Operate
THE CUSTOMER REPORTED THAT WHEN HE WAS PLACING A TB SKIN TEST AND HAD ENGAGED THE SAFETY WHICH PUTS A COVER OVER THE TOP PORTION. PER CUSTOMER, HE WENT TO PUT THE CAP ON TO DISCARD AND NOTICED THAT THE SAFETY DISENGAGED. HE WAS ABLE TO REPLICATE IT WITH TWO OTHER NEEDLES, THE SAFETY DISENGAGES WITH LIGHT PRESSURE. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14434865 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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