Class II — EMPATICA SRL
| Recalling firm | Empatica S.r.l. |
|---|---|
| Registered facility | GKC MANUFACTURING PTY LTD (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently. |
| 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 |
| Quantity | 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. |
| Initiated | 2023-07-13 |
| Classified | 2023-10-24 |
| Recall number | Z-0159-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — EMPATICA SRL (Z-0159-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93215/
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