Medline SYR103253Recalls & reported problems
Medline Industries, Inc. · SYRINGE, LL, 3ML, 25GX 5/8" · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 30080196449563), received between Mar 18, 2024 and Apr 4, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak3
- Leak/Splash1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 4, 2024Fluid/Blood Leak; Material Integrity Problem; Fluid/Blood Leak; Material Integrity Problem
IT WAS REPORTED THAT THE SYRINGE WAS "DAMAGED" AND THAT A FLU VACCINE "SHOT OUT OF THE TOP OF THE SYRINGE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19039072 ↗MalfunctionApr 1, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT MEDICATION LEAKED BEHIND THE SYRINGE PLUNGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19016240 ↗MalfunctionApr 1, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT MEDICATION LEAKED BEHIND THE SYRINGE PLUNGER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19009705 ↗MalfunctionMar 18, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT MEDICATION LEAKAGE WAS NOTED FROM A SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18921810 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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