Severity
Moderate
ModerateClass IICompleted
FDA Devices recall · Reported August 22, 2018
Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive
Device could not meet the requirements for systolic pressure
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Withings Sas recalled Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressur… - a moderate-severity action.
Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressur… was recalled by Withings Sas in August 22, 2018. Reason: Device could not meet the requirements for systolic pressure. Check the official notice for the remedy. Verify recall #Z-2829-2018 with the FDA Devices before acting.
The recall
Withings Sas issued this moderate-severity FDA Devices recall-Device could not meet the requirements for systolic pressure.
- Moderate
- severity level
- Class II
- classification
- August 22, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2829-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2829-2018) was formally reported on August 22, 2018, with the manufacturer initiating the action on June 11, 2018. It is classified under Moderate severity (Class II), with a current status of Completed. Withings Sas is listed as the recalling firm, operating out of Issy les Moulineaux. Federal records list the affected scope as Total 44,000 units (15,139 US/ 28,861 OUS).
The documented reason for this recall is: Device could not meet the requirements for systolic pressure Distribution data in the federal record shows the product reached: US Nationwide Distribution. 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 - 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 - 40,422 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
Total 44,000 units (15,139 US/ 28,861 OUS)
Related Recalls
6
0 from same agency
Product description
Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive
Reason for recall
Device could not meet the requirements for systolic pressure
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Completed |
| Recall number | Z-2829-2018 |
| Date reported | August 22, 2018 |
| Date initiated | June 11, 2018 |
| Recalling firm | Withings Sas |
| Firm location | Issy les Moulineaux |
| Affected scope | Total 44,000 units (15,139 US/ 28,861 OUS) |
| Distribution | US Nationwide Distribution |
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-2829-2018) 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? ▼
Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive. Recalled by Withings Sas. Units affected: Total 44,000 units (15,139 US/ 28,861 OUS).
Why was this product recalled? ▼
Device could not meet the requirements for systolic pressure
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 22, 2018. Severity: Moderate. Recall number: Z-2829-2018.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2829-2018) 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.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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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 22, 2018. 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.