Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Syringes with Luer Slip Tips labeled as: 1) SOL-M 1ml Recalled by Sol-Millennium Medical Inc. Due to Products in distribution were found by FDA to...

Date: May 9, 2024
Company: Sol-Millennium Medical Inc.
Status: Ongoing
Source: FDA (Device)

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 Luer Slip Tips labeled as: 1) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. 180011, UPC 8183923010138; 2) SOL-M 1ml Slip Tip Syringe w/o Needle, Model No. P180011, UPC 810018097523; 3) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. 180020ST, UPC 840368511998; 4) SOL-M 3ml Slip Tip Syringe w/o Needle, Model No. P180003ST, UPC 810018097493; 5) SOL-M 5ml Slip Tip Syringe w/o Needle, Model No. P180005ST, UPC 810018097462; 6) SOL-M 10ml Slip Tip Syringe w/o Needle, Model No. P180010ST, UPC 810018097646; 7) SOL-M 20ml Slip Tip Syringe w/o Needle, Model No. P180020ST, UPC 810018098636; 8) SOL-M 30ml Slip Tip Syringe w/o Needle, Model No. P180030ST, UPC 810062435333; 9) SOL-M 60ml Slip Tip Syringe w/o Needle, Model No. P180060ST, UPC 810062435340; 10) SOL-M 1ml Slip Tip Syringe Sterile Convenience Tray, Model No. P180011T, UPC 810018098957

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.

Affected (51 states)Not affected

About Sol-Millennium Medical Inc.

Sol-Millennium Medical Inc. has 6 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report