SOL-M Syringe P180020Recalls & reported problems
Sol-Millennium Medical, Inc. · SOL-M 20ml Luer Lock Syringe w/o Needle · Class 2
All models of SOL-M Syringe (5)
Data updated Oct 18, 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 00818392018240), received between May 16, 2025 and Sep 18, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. 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
- Break1
- Contamination1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2025Break; Break
CUSTOMER REPORTED TWO INCIDENTS THAT THE HUB OF THE SYRINGE BROKE OFF WHILE PREPARING A STENT, SO WE HAD TO OPEN AN ADDITIONAL STENT. NO SAMPLES AVAILABLE. UPON CONNECTING 20ML L/L SYRINGE TO A CORONARY STENT SHEATH, THE LUER LOCK SNAPPED AND REMAINED INSIDE THE STENT SHEATH ENTRY PORT RENDERING THE STENT UNUSABLE. NO SAMPLES AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23082772 ↗MalfunctionMay 16, 2025Contamination; Contamination
CUSTOMER REPORTED: WE FOUND THAT THERE IS A HAIR INSIDE THE PISTON OF THE SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22035527 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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