Withings Recalls Nokia BPM+ Wireless Blood Pressure Monitors
Withings is recalling Nokia BPM+ Wireless Blood Pressure Monitors because the devices may not meet requirements for systolic pressure.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a medical device failing to meet performance requirements for systolic pressure, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Withings Sas is recalling the Nokia BPM+ Wireless Blood Pressure Monitor. The recall involves a total of 44,000 units, with 15,139 units distributed in the United States and 28,861 units distributed outside the United States. The product was distributed nationwide in the US.
The recall was initiated because the device could not meet the requirements for systolic pressure. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers who have this product should stop using it and contact Withings for further instructions. The recall number is Z-2829-2018.
The recalled product
- Product
- Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive
- Manufacturer
- Withings Sas
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 7024260310
Distribution
Distributed nationwide across the United States.
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