RegWardenFDA facility compliance records
Recall

Class II — Hero Health

Recalling firmHero Health, Inc.
Registered facilityHERO HEALTH, Inc. (the firm's only registered facility)
ClassificationClass II
StatusTerminated
ReasonDue to dispenser prompting for a missed dose that had already been dispensed
ProductThe Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.
Quantity12,039 units which had software version V2.04.012
DistributionU.S. Nationwide distribution.
Initiated2021-07-02
Classified2021-09-10
Terminated2023-11-02
Recall numberZ-2443-2021
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Hero Health (Z-2443-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88389/

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