Sol-Millennium Medical Inc.: Medical Device Recall in 2024 - (Recall #: Z-3077-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Eccentric Tip Syringe w/o Needle, Model No. P180020ET, UPC 810018098605; 3) SOL-M 60ml Eccentric Tip Syringe w/o Needle, Model No. P180060ET, UPC 810018098698;

Product Classification:

Class II

Date Initiated: May 9, 2024

Date Posted: September 18, 2024

Recall Number: Z-3077-2024

Event ID: 94968

Reason for Recall:

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.

Status: Ongoing

Product Quantity:

Code Information:

1) Model No. P180010ET, Lot Numbers: 4209010; 2) Model No. P180020ET, Lot Numbers: 4209011; 3) Model No. P180060ET, Lot Numbers: 4209009, 4209011;

Distribution Pattern:

US Nationwide, Czech Republic, Belgium, Portugal, Canada, Saudi Arabia, Netherland, France, Switzerland, Latvia, UK, Spain, Germany, Philippines, Australia, Malaysia, Jamaica, Slovenia, Brazil, Taiwan, Denmark, Sweden, Singapore, Romania, Poland, Barbados, Mexico, Guatemala, Chile, Ireland, Italy, Panama

Voluntary or Mandated:

Voluntary: Firm initiated