Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System Recalled by Biointellisense Inc. Due to Software anomaly causing the skin temperature measurement accuracy...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Biointellisense Inc. directly.
Affected Products
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.
Quantity: 135,414 devices (U.S. 95,414 and O.U.S. 40,000)
Why Was This Recalled?
Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
Where Was This Sold?
This product was distributed to 5 states: CA, CO, MA, TN, TX
About Biointellisense Inc.
Biointellisense Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report