Z-2443-2021Class II

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

Name: Z-2443-2021 The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app
Creator: Hero Health
Published: 2021-07-02
License: https://open.fda.gov/license/

HERO HEALTH, Inc. / initiated 2021-07-02 / Terminated

FDA source

Hero Health began a recall of The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app on 2021-07-02. FDA classified it as Class II and gives the reason as "Due to dispenser prompting for a missed dose that had already been dispensed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2443-2021
Classification: Class II
Status: Terminated
Initiated: 2021-07-02
Posted: 2021-09-10
Terminated: 2023-11-02
Recalling firm: HERO HEALTH, Inc.
Product: The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.
Product code: NXB Dispenser, Solid Medication
Reason for recall: Due to dispenser prompting for a missed dose that had already been dispensed
FDA root cause: Under Investigation by firm
Action: On 07/02/2021, the firm initially sent out an "URGENT NOTICE" via email notifying customers of an product update correction. Customers were informed that the firm had become aware that a recent firmware update (v2.4.12) that users have experienced an error, which caused improper recording of a dispensed dose as having not been dispensed. This error may prompt a user to dispense the same dose again, and the mobile app will indicate that the previously dispensed dose has not been taken yet. Customers are instructed to: -If the pill dispenser prompts you to re-dispense a scheduled dose which has already been dispensed today, select Skip. -Use extra caution when dispensing doses prior to the scheduled firmware update and verify that the pill dispenser has a working internet connection. This will ensure that the firmware update (v2.4.14) will be automatically applied on all potentially affected online pill dispensers (at approximately 2:00 AM on July 3, 2021) to correct the issue. -To manually update firmware immediately, follow these steps: 1) Ensure the Pill Dispenser is connected to WiFi (Check for the WiFi icon on the main screen). 2) Go to the Device menu, by pressing the Center button on the main screen. 3) Scroll down and select Device Settings . 4) Scroll down and select Firmware Update. 5) Select I m Ready. The update could take several minutes. It is recommended to run the firmware update at least 30 minutes before a scheduled dose. -If the pill dispenser is not connected to WiFi, the firmware update cannot be completed. In this event, contact the Recalling Firm's Member support for assistance before continuing to use the pill dispenser to ensure the update is applied as soon as possible For question or further assistance, contact the Recalling firm at 855-855-9962 or via email at [email protected] (24/7).
Quantity in commerce: 12,039 units which had software version V2.04.012
Distribution: U.S. Nationwide distribution.
Product codes and lots: Model 100 (H-100) Catalog Number: F00002 Hero 100 V1.4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2443-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2443-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-22	2021-09-10

Product code NXB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)