EMPATICA SRL: Medical Device Recall in 2023 - (Recall #: Z-0159-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: July 13, 2023

Date Posted: November 1, 2023

Recall Number: Z-0159-2024

Event ID: 93215

Reason for Recall:

May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.

Status: Ongoing

Product Quantity: 1360 units

Code Information:

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 Pattern:

Worldwide distribution - US Nationwide and the countries of Italy, Ireland, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Germany, Finland, Netherlands, Poland, Sweden.

Voluntary or Mandated:

Voluntary: Firm initiated