Embrace2- Indicated for use as an adjunct to seizure monitoring of… — Class II medical device recall Z-0159-2024
Ongoing recall by EMPATICA SRL, reported 2023-11-01, distributed nationwide. May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequentl
| Recall number | Z-0159-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | EMPATICA SRL, Milan, N/A, Italy |
| Recall initiated | 2023-07-13 |
| Classified | 2023-10-24 |
| Reported by FDA | 2023-11-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, BG, CY, CZ, DE, DK, FI, IE, IT, NL, PL, SE |
| Quantity | 1,360 units |
| UPC / GTIN / UDI-DI | 00853858006102, 00853858006119, 00853858006126, 00853858006133, 00853858006140 |
| Lot numbers | G11/H11 |
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 for recall
May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0159-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.