Class II

Medical Device Recall: Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No

Hologic, Inc. · February 18, 2026

Reason for Recall

Due to product exhibiting potential to generate either invalid or false negative results.

Distribution

U.S. Nationwide distribution in the states of CA, FL. IA, IL, MO, NC, NM, PR, and TN.

States Affected

NATIONWIDE

Quantity Affected

306

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1586-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.