Sol-Millennium Medical Inc.: Medical Device Recall in 2024 - (Recall #: Z-3079-2024)

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:

Syringe Tip Caps labeled as: 1) SOL-M Syringe Tip Cap, Blue, Model No. STCB01, UPC N/A; 2) SOL-M Syringe Tip Cap, Red, Model No. STCB02, UPC N/A; 3) SOL-M Red Cap, Model No. 110101150020, UPC N/A 4) SOL-M Syringe Tip Cap Tray, Black, Model Number STCT01, UPC N/A

Product Classification:

Class II

Date Initiated: May 9, 2024

Date Posted: September 18, 2024

Recall Number: Z-3079-2024

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. STCB01, UPC N/A, LOT NUMBERS: 4201063, 4209005, 4307016, 4308061, 4311036; 2) Model No. STCB02, UPC N/A, LOT NUMBERS: 4201064; 3) Model No. 110101150020, UPC N/A LOT NUMBERS: EXPIRED 4) Model No. STCT01, UPC: Sole in Canada only, LOT NUMBERS: 4301023, 4308072, 4308073, 4309043, 4310029, 04311037, 4312011, 4312093, 4402006

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