FDA Device recall Z-2616-2024
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous c…
- FDA Device
- Class II
- ongoing
- Published 2024-08-21
On 2024-08-21 the FDA classified a Class II recall of BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous c… by Biointellisense, citing software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2616-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-07-19 |
| Published | 2024-08-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Biointellisense |
| Distribution | CA, CO, MA, TN, TX |
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
Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
Identifiers
| code_info | Part Number: BIOST06040 UDI-DI code: 00850005949299 UDI code/Lot Number /BioID: U.S. 01008500059492991095422964 9542296…Part Number: BIOST06040 UDI-DI code: 00850005949299 UDI code/Lot Number /BioID: U.S. 01008500059492991095422964 95422964 1897-529-643 01008500059492991095422964 95422964 2273-984-549 01008500059492991095422964 95422964 2353-391-610 01008500059492991095422964 95422964 1983-418-284 01008500059492991095422964 95422964 2197-213-247 01008500059492991095422964 95422964 2195-552-499 01008500059492991095422964 95422964 0776-970-222 01008500059492991095422964 95422964 0759-262-015 01008500059492991095422964 95422964 0693-068-049 01008500059492991095422964 95422964 1037-592-544 01008500059492991095422964 95422964 0586-886-801 01008500059492991095422964 95422964 0725-951-385 01008500059492991095422964 95422964 2837-953-215 01008500059492991095422964 95422964 1908-223-951 01008500059492991095422964 95422964 1564-661-854 01008500059492991095422964 95422964 1371-357-677 01008500059492991095422964 95422964 1491-596-810 01008500059492991095422964 95422964 1300-630-104 01008500059492991095422964 954229 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2616-2024%22
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