Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M Recalled by Sol-Millennium Medical Inc. Due to Products in distribution were found by FDA to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Sol-Millennium Medical Inc. directly.
Affected Products
Syringes with Fixed Needles labeled as: a) SOL-M: 1) SOL-M 1ml TB Syringe w/Fixed Needle 25G*5/8'', Model No. 181025, UPC 818392014884; 2) SOL-M 3ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1831815B, UPC 818392011593; 3) SOL-M 5ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1851815B, UPC 818392011609; 4) SOL-M 10ml Luer Lock Syringe w/Blunt Fill Needle 18G*1 1/2'', Model No. 1811815B, UPC 818392011616;
Why Was This Recalled?
Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sol-Millennium Medical Inc.
Sol-Millennium Medical Inc. has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report