Recall Record

Sarasota, FL, United States

Home Health US, Incorporated recalls

1 recall recorded since 2018, most recently on 25 July 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class III Medical devices

Recall started
25 July 2025
Reason
Due to incorrect/lack of Unique Device Identifier (UDI) codes.
Distribution
U.S.: Nation-wide distributed thru Amazon U.S. States include: AZ, CA, FL, IL, NC, NM, NY, TN, TX, and VA. O.U.S.: N/A
Initiated
Voluntary: Firm initiated
Recall number
Z-0226-2026

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.