Empatica recalls Embrace2 seizure monitoring devices due to potential battery life issues requiring more frequent charging than advertised.
May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.
Empatica is recalling its Embrace2 devices for seizure monitoring in children age 6 and up. The devices may need charging more often than the 48-hour battery life suggests, which could affect consistent seizure monitoring.
The Embrace2 device may not last the full 48 hours on a single charge, requiring more frequent charging. This could lead to inconsistent seizure monitoring if the device runs out of power unexpectedly.
Parents and caregivers of children age 6 and older who use the Embrace2 for home seizure monitoring are most at risk. The recall affects specific color models sold with certain lot numbers.
Check for the device color: Flamingo Pink, Sky Blue, Seoul Grey, Boston Blue, or Milan Black. Look for the model codes (EM2-FP-S, EM2-SB-2, etc.) and lot numbers G11 or H11.
Identify the device color and model code (e.g., EM2-FP-S for Flamingo Pink) to confirm if it's affected.
Reach out to Empatica SRL for further assistance if you have the recalled model.
The Embrace2 may need charging more frequently than the 48-hour battery life suggests, which could affect consistent seizure monitoring.
Flamingo Pink (EM2-FP-S), Sky Blue (EM2-SB-2), Seoul Grey (EM2-SG-S), Boston Blue (EM2-BB-S), and Milan Black (EM2-MB-S) models with lot numbers G11 or H11.
No, the recall does not require stopping use. The device may need more frequent charging but is still safe to use.
We’ve drafted a message you can send Empatica to request your refund or repair — edit it as you like.
Subject: Recall Z-0159-2024 — Empatica Empatica Hello, I own a Empatica that is covered by recall Z-0159-2024 from Empatica. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
