Class II — Withings Sas
| Recalling firm | Withings (France) |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Completed |
| Reason | Device could not meet the requirements for systolic pressure |
| Product | Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive |
| Quantity | Total 44,000 units (15,139 US/ 28,861 OUS) |
| Distribution | US Nationwide Distribution |
| Initiated | 2018-06-11 |
| Classified | 2018-08-16 |
| Recall number | Z-2829-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Withings Sas (Z-2829-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80533/
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