Reported Nov 1, 2023 · Ongoing

Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or…

Empatica Srl

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: EMPATICA SRL · Via Enrico Stendhal 36 · Milan, N/A · N/A

Is this the product you have?

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

5 of 5 products

Products covered by this recall
#Product as published
1(1) Flamingo Pink EM2-FP-S
2(2) Sky Blue EM2-SB-2
3(3) Seoul Grey EM2-SG-S
4(4) Boston Blue EM2-BB-S
5(5) Milan Black EM2-MB-S
Lot codes and dates

5 of 5 products

Products covered by this recall
#BarcodesProduct as published
100853858006133(1) Flamingo Pink EM2-FP-S - 00853858006133
200853858006140(2) Sky Blue EM2-SB-2 - 00853858006140
300853858006126(3) Seoul Grey EM2-SG-S - 00853858006126
400853858006119(4) Boston Blue EM2-BB-S - 00853858006119
500853858006102(5) Milan Black EM2-MB-S - 00853858006102 Lot Numbers: G11/H11
Amount recalled
1360 units

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:18 PM UTC

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