FDA recall Z-2443-2021

Hero Health · Class II · device

Product

The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.

Reason for recall

Due to dispenser prompting for a missed dose that had already been dispensed

Distribution

U.S. Nationwide distribution.

Key facts

Status
Terminated
Initiation date
2021-07-02
Report date
2021-09-22
Termination date
2023-11-02
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hayward, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2443-2021