BioButton REF BIOST06040 with Software version 3 — Class II medical device recall Z-2616-2024
Ongoing recall by Biointellisense Inc., reported 2024-08-21, distributed in CA, CO, MA, TN, TX. Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
| Recall number | Z-2616-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biointellisense Inc., Redwood City, CA, United States |
| Recall initiated | 2024-07-19 |
| Classified | 2024-08-14 |
| Reported by FDA | 2024-08-21 |
| Distributed | CA, CO, MA, TN, TX |
| Reason classes | specification failure, software |
| UPC / GTIN / UDI-DI | 00850005949220, 00850005949299, 92991095440943, 92991095550239 |
| Model numbers | BIOST06040 |
Product
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.
Reason for recall
Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
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-2616-2024. 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.