FDA Medical Device Recalls (openFDA)
Hero Health: The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.
- Recall number
- Z-2443-2021
- Recalling firm
- Hero Health
- Product
- The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.
- Status
- Terminated
- Initiated
- 2021-07-02
- Posted
- not on file
- Terminated
- 2023-11-02
- Reason
- Due to dispenser prompting for a missed dose that had already been dispensed
- 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 hello@herohealth.com (24/7).
- Quantity
- 12,039 units which had software version V2.04.012
- Distribution
- U.S. Nationwide distribution.
- Lot, serial or model codes
- Model 100 (H-100) Catalog Number: F00002 Hero 100 V1.4
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NXB
- Firm FEI
- 3014660737
- Firm city
- Hayward
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28