Monoject 1183500555Recalls & reported problems
Cardinal Health, Inc. · 35 mL Syringe,Regular Tip · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521010819), received between Sep 14, 2020 and Jun 15, 2021 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Break” (5 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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Break5
- Contamination2
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- No Patient Involvement1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 15, 2021Break; Break
THE CUSTOMER REPORTED THEY DETECTED DURING INCOMING INSPECTION, SYRINGES WITH DAMAGE TO THE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11999242 ↗MalfunctionJun 9, 2021Break; Contamination; Break; Contamination
THE CUSTOMER REPORTED THAT DURING INCOMING INSPECTION, THE ADDITIONAL SAMPLING CONFIRMED THAT FEW SYRINGES HAD DAMAGED TIP. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11968295 ↗MalfunctionMay 6, 2021Contamination; Contamination
THE CUSTOMER REPORTED THAT DURING INSPECTION IN THE PRODUCTION LINE, THE TEAM DETECTED SYRINGE BARREL HAS FLASH IN THE TIP AND THERE ARE BURRS CAUGHT INSIDE THE BARREL AND PLUNGER. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11787246 ↗MalfunctionApr 14, 2021Break; Break
THE CUSTOMER REPORTED THAT THE SYRINGE WAS FOUND WITH SHORT SHOT IN THE TIP. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11665642 ↗MalfunctionApr 14, 2021Break; Break
THE CUSTOMER REPORTED THAT THE SYRINGE WAS FOUND WITH SHORT SHOT IN THE TIP. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11665348 ↗MalfunctionSep 14, 2020Break; Break
CUSTOMER REPORTS: THE TIP OF SYRINGE WAS FOUND BROKEN BEFORE ASSEMBLING THE SYRINGE TO A SUB-ASSEMBLY UNIT.
Patient problems: No Patient Involvement
MAUDE report 10531713 ↗
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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 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.
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