The Recall Desk
HighFDA (Devices)·Z-2443-2021·Announced 2021-09-22

Hero Model 100 Smart Pill Dispenser Recalled for Software Dose-Prompting Error

Hero Health is recalling the Model 100 smart pill dispenser due to a software defect causing the device to prompt users to take medication doses that have already been dispensed, creating overdose risk.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device defect. The software error creates potential for unintended double-dosing of medication. Although FDA Class II indicates agency concern, absence of reported injuries limits the severity to High per the rubric for risk-of-harm products without materialized harm.

Plain-English summary

Hero Health is recalling the Hero Model 100 (H-100) smart pill dispenser and its associated medication management app due to a software defect. The recall involves 12,039 units with software version V2.04.012 distributed nationwide throughout the United States.

The defect causes the dispenser to prompt users to take medication doses that have already been dispensed. This creates the potential for users to take duplicate doses of their medication, which could result in medication overdose or other adverse effects from excessive medication dosing.

Further information about this recall is available through Hero Health and the FDA.

The recalled product

Product
The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.
Manufacturer
Hero Health
Category
Medical Device
Hazard
  • medication-error
  • overdose-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Model 100 (H-100) Catalog Number: F00002 Hero 100 V1.4

Distribution

Distributed nationwide across the United States.

Related recalls

Same category