USA Medical, LLC: Medical Device Recall in 2022 - (Recall #: Z-1050-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Diagnostic Kit SARS-cCo V Antigen Rapid Test

Product Classification:

Class II

Date Initiated: April 4, 2022

Date Posted: May 18, 2022

Recall Number: Z-1050-2022

Event ID: 90098

Reason for Recall:

COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.

Status: Ongoing

Product Quantity: 2055 kits

Code Information:

Catalog/Model/Part Number: None UDI Code: None Lot Numbers: Unknown/None

Distribution Pattern:

U.S. Nationwide distribution in the states of CA, FL, IN, MD, MO, NJ, OK, and TN.

Voluntary or Mandated:

Voluntary: Firm initiated