FDA Device recall Z-0159-2024
Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or healthcare facilities during…
- FDA Device
- Class II
- ongoing
- Published 2023-11-01
On 2023-11-01 the FDA classified a Class II 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… by Empatica Srl, citing may have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0159-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-13 |
| Published | 2023-11-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Empatica Srl |
| Distribution | US |
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
Reason
May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.
Identifiers
| code_info | UDI-DI: (1) Flamingo Pink EM2-FP-S - 00853858006133; (2) Sky Blue EM2-SB-2 - 00853858006140; (3) Seoul Grey EM2-SG-S…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0159-2024%22
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