SOL-M Syringe P180003Recalls & reported problems
Sol-Millennium Medical, Inc. · SOL-M 3ml Luer Lock Syringe w/o Needle · Class 2
All models of SOL-M Syringe (5)
Data updated Oct 16, 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 00818392018172), received between May 16, 2025 and Jul 23, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Discolored” (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
- Material Discolored3
- Compatibility Problem1
- Crack1
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.
MalfunctionJul 23, 2025Crack; Crack
CUSTOMER REPORTED THAT THE BARREL CRACKED DOWN LENGTH OF BARREL SO LEAKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22574108 ↗MalfunctionMay 16, 2025Material Discolored; Compatibility Problem; Material Discolored; Compatibility Problem
CUSTOMER REPORTED THAT THE MEDICATION CHANGES COLOR WHEN IN SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035726 ↗MalfunctionMay 16, 2025Material Discolored; Material Discolored
CUSTOMER REPORTED THAT THE ISSUE IS THAT AFTER MEDICATION IS BEING DRAWN INTO THE SYRINGES, THE MEDICATION IS TURNING COLORS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035704 ↗MalfunctionMay 16, 2025Material Discolored; Material Discolored
"CUSTOMER REPORTED THAT THE MEDICATION CHANGES COLOR WHEN IN SYRINGE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035437 ↗
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.
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