Z-0159-2024Class II

Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home...

Name: Z-0159-2024 Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home...
Creator: Empatica Srl
Published: 2023-07-13
License: https://open.fda.gov/license/

EMPATICA S.r.l. / initiated 2023-07-13 / Open, Classified / root cause: design

FDA source

EMPATICA SRL began a recall of 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... on 2023-07-13. FDA classified it as Class II and gives the reason as "May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0159-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-13
Posted: 2023-10-24
Recalling firm: EMPATICA S.r.l.
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 EM2-BB-S; (5) Milan Black EM2-MB-S
Product code: POS Physiological Signal Based Seizure Monitoring System
Reason for recall: May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.
Root cause tag: design
FDA root cause: Device Design
Action: Empatica S.r.l issued Field Safety Notice via email on 7/14/23. Letter states reason for recall, health risk and action to take: You can check your device lot number by: " From the Alert App On the home page of your MyEmbrace account on the right hand side of the screen you will see your Embrace Serial Number. The lot number is represented by the 5th, 6th and 7th digit of the serial number. " On the packaging of your device On the box that contained your Embrace2 there is an identification label (See picture below). The device Lot number is identified with the LOT symbol. In the picture below the device Lot number is F11. Empatica recommends that you pay increased attention to the product battery level notifications intended to inform you about the remaining battery charge. As noted in the user manual, the Embrace device is not intended to be used as a stand-alone monitoring device. As the system is not meant to substitute for ongoing seizure monitoring practices, patients are strongly advised to ensure that alternative methods of obtaining medical assistance are available at all times, including during device charging sessions Patients are also encouraged to contact Empatica customer support for any concern related to battery life impacting usability of the Embrace device. Customers contacted by the Empatica customer support team regarding battery duration are offered a free-of-charge replacement device.
Quantity in commerce: 1360 units
Distribution: Worldwide distribution - US Nationwide and the countries of Italy, Ireland, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Germany, Finland, Netherlands, Poland, Sweden.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0159-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0159-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-01	2023-10-24

Product code POS

K181861Class IIEmbraceEmpatica S.r.l. / cleared 2018-12-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)