Data Foundry

Medical device recalls 2021

The Hero Model 100 — Class II medical device recall Z-2443-2021

Terminated recall by Hero Health, reported 2021-09-22, distributed nationwide. Due to dispenser prompting for a missed dose that had already been dispensed

Recall numberZ-2443-2021
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmHero Health, Hayward, CA, United States
Recall initiated2021-07-02
Classified2021-09-10
Reported by FDA2021-09-22
Terminated2023-11-02
DistributedNationwide (US)
Quantity12,039 units
Model numbers100, F00002

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2443-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.