Embrace2 Seizure Monitor Recalled for Reduced Battery Life
Empatica has recalled 1,360 units of its Embrace2 seizure monitoring wearable due to potential battery life lasting less than the specified 48 hours, requiring more frequent charging.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported injuries or illnesses. The hazard is a functional performance deficiency requiring more frequent device charging. No documented harm has been reported, classifying this as a voluntary precautionary recall.
Plain-English summary
The Embrace2 is a wearable medical device designed as an adjunct to seizure monitoring in adults and children age 6 and up, for use during rest periods in home or healthcare settings. Empatica SRL has recalled 1,360 units of the device.
The recall was initiated because affected devices may have a battery life lasting less than the full 48 hours, requiring more frequent charging than intended.
The affected units include multiple color models and carry lot numbers G11 and H11. These units were distributed worldwide, including throughout the United States and across multiple European countries including Italy, Ireland, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Germany, Finland, Netherlands, Poland, and Sweden.
The recalled product
- Product
- Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during periods of rest. Models: (1) Flamingo Pink EM2-FP-S; (2) Sky Blue EM2-SB-2; (3) Seoul Grey EM2-SG-S; (4) Boston Blue…
- Manufacturer
- EMPATICA SRL
- Hazard
- Affected units
- 1,360
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 (5)
- UDI-DI: (1) Flamingo Pink EM2-FP-S - 00853858006133
- (2) Sky Blue EM2-SB-2 - 00853858006140
- (3) Seoul Grey EM2-SG-S - 00853858006126
- (4) Boston Blue EM2-BB-S - 00853858006119
- (5) Milan Black EM2-MB-S - 00853858006102 Lot Numbers: G11/H11
Distribution
Distributed nationwide across the United States.
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