Medical device recalls Moderate risk

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

Recall date
July 2, 2021
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2443-2021
FDA classification
Class II
Brand / firm
Hero Health
Sold / distributed
U.S. Nationwide distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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