Church & Dwight Inc: Medical Device Recall in 2023 - (Recall #: Z-1350-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Easy Read App associated with First Response Pregnancy Test Sticks - Intended use of converting analog pregnancy test results into text pregnant or not pregnant for display on consumer devices (e.g., smart phone, iPad)

Product Classification:

Class II

Date Initiated: January 25, 2023

Date Posted: April 19, 2023

Recall Number: Z-1350-2023

Event ID: 91758

Reason for Recall:

Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There is also a potential for Easy Read App to be unable to reads the test results (i.e., no results reported on the APP screen) or to misread the analog results shown on the pregnancy test stick and may lead to misinterpretation of false positive or false negative tests by the user.

Status: Ongoing

Product Quantity: 780000 downloads

Code Information:

All lots with the Easy Read App

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated