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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Monitoring Devices

EMPATICA SRL: Embrace2 Seizure Monitoring Devices Recalled for Shortened Battery Life

Agency Publication Date: October 24, 2023
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Summary

Empatica SRL is recalling approximately 1,360 units of its Embrace2 seizure monitoring watch because the battery life may last less than the promised 48 hours. This defect requires users to charge the device more frequently than expected, which could lead to the device powering off unexpectedly and failing to monitor for seizures. The recall affects several colors including Flamingo Pink, Sky Blue, Seoul Grey, Boston Blue, and Milan Black distributed worldwide.

Risk

If the battery drains faster than 48 hours, the device may shut down without the user's knowledge, resulting in a failure to monitor and alert caregivers during a seizure event. This poses a risk of serious injury or delayed medical intervention for individuals with epilepsy.

What You Should Do

  1. Identify if your device is affected by checking the model name and color: Embrace2 in Flamingo Pink (EM2-FP-S), Sky Blue (EM2-SB-2), Seoul Grey (EM2-SG-S), Boston Blue (EM2-BB-S), or Milan Black (EM2-MB-S).
  2. Verify the Lot Numbers and UDI-DI on your device packaging or documentation: look for Lot Numbers G11 or H11.
  3. Match the UDI-DI barcode numbers: Flamingo Pink (00853858006133), Sky Blue (00853858006140), Seoul Grey (00853858006126), Boston Blue (00853858006119), or Milan Black (00853858006102).
  4. Monitor your device's battery level closely and charge it more frequently than every 48 hours to ensure continuous monitoring.
  5. Contact your healthcare provider or Empatica SRL at their Milan, Italy headquarters via their website or the contact information provided in their initial email notification for further instructions regarding a potential remedy or replacement.
  6. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer instructions via email notification.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Embrace2 Seizure Monitor (Flamingo Pink)
Model / REF:
EM2-FP-S
UPC Codes:
00853858006133
Lot Numbers:
G11
H11
Product: Embrace2 Seizure Monitor (Sky Blue)
Model / REF:
EM2-SB-2
UPC Codes:
00853858006140
Lot Numbers:
G11
H11
Product: Embrace2 Seizure Monitor (Seoul Grey)
Model / REF:
EM2-SG-S
UPC Codes:
00853858006126
Lot Numbers:
G11
H11
Product: Embrace2 Seizure Monitor (Boston Blue)
Model / REF:
EM2-BB-S
UPC Codes:
00853858006119
Lot Numbers:
G11
H11
Product: Embrace2 Seizure Monitor (Milan Black)
Model / REF:
EM2-MB-S
UPC Codes:
00853858006102
Lot Numbers:
G11
H11

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93215
Status: Active
Manufacturer: EMPATICA SRL
Sold By: Direct from Manufacturer; Healthcare facilities
Manufactured In: Italy
Units Affected: 1360 units
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.