Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 21, 2024
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.
Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
Biointellisense Inc. recalled BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote… - a moderate-severity action.
BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote… was recalled by Biointellisense Inc. in August 21, 2024. Reason: Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.. Check the official notice for the remedy. Verify recall #Z-2616-2024 with the FDA Devices before acting.
The recall
Biointellisense Inc. issued this moderate-severity FDA Devices recall-Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification..
- Moderate
- severity level
- 135K units
- affected scope
- Class II
- classification
- August 21, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2616-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2616-2024) was formally reported on August 21, 2024, with the manufacturer initiating the action on July 19, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Biointellisense Inc. is listed as the recalling firm, operating out of Redwood City, CA. Federal records list the affected scope as 135,414 devices (U.S. 95,414 and O.U.S. 40,000), a scale large enough to require multi-state distribution tracking.
The documented reason for this recall is: Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification. Distribution data in the federal record shows the product reached: U.S.: CA, CO, MA, TN, and TX O.U.S.: not provided. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
135,414 devices (U.S. 95,414 and O.U.S. 40,000)
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2616-2024 |
| Date reported | August 21, 2024 |
| Date initiated | July 19, 2024 |
| Recalling firm | Biointellisense Inc. |
| Firm location | Redwood City, CA |
| Affected scope | 135,414 devices (U.S. 95,414 and O.U.S. 40,000) |
| Distribution | U.S.: CA, CO, MA, TN, and TX O.U.S.: not provided |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2616-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Biointellisense Inc.. Units affected: 135,414 devices (U.S. 95,414 and O.U.S. 40,000).
Why was this product recalled? ▼
Software anomaly causing the skin temperature measurement accuracy to be slightly out of specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 21, 2024. Severity: Moderate. Recall number: Z-2616-2024.
Where was the recalled product distributed? ▼
Distribution: U.S.: CA, CO, MA, TN, and TX O.U.S.: not provided.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2616-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 21, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.