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
| # | 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 # Barcodes Product as published 1 00853858006133(1) Flamingo Pink EM2-FP-S - 00853858006133 2 00853858006140(2) Sky Blue EM2-SB-2 - 00853858006140 3 00853858006126(3) Seoul Grey EM2-SG-S - 00853858006126 4 00853858006119(4) Boston Blue EM2-BB-S - 00853858006119 5 00853858006102(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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