Class IIReported 2025-12-10

HPV Antigen Test

Reason for Recall

Distribution without premarket approval/clearance.

Recall Number

Z-0741-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2025-11-03

Reported

2025-12-10

Distribution

US Nationwide distribution.

Code Info

EAN: 7340221708259; SKU: A-HPV; UDI-DI: None; Lot/Serial Number: All Lots;

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.