# FDA recall Z-0159-2024

> **EMPATICA SRL** · Class II · device recall initiated 2023-07-13.

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-0159-2024
- **Recalling firm:** EMPATICA SRL
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-07-13
- **Report date:** 2023-11-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Milan, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0159-2024

## Citation

> AI Analytics. FDA recall Z-0159-2024. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0159-2024. Source: US FDA. Licensed CC0.

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