Recall archive / FDA device enforcement
Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up in home or health... — FDA record Z-0159-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jul 13, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.
- Classification
- Class II
- Recalling firm
- EMPATICA SRL
- Quantity
- 1360 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0159-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: (1) Flamingo Pink EM2-FP-S - 00853858006133; (2) Sky Blue EM2-SB-2 - 00853858006140; (3) Seoul Grey EM2-SG-S - 00853858006126; (4) Boston Blue EM2-BB-S - 00853858006119; (5) Milan Black EM2-MB-S - 00853858006102 Lot Numbers: G11/H11 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide and the countries of Italy, Ireland, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Germany, Finland, Netherlands, Poland, Sweden.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Nov 1, 2023
- Recall initiation date
- Jul 13, 2023
- Center classification date
- Oct 24, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.