CLASS II ONGOING Device recall · Reported 1 Nov 2023 · FDA Enforcement Report
Embrace2- Indicated for use as an adjunct to seizure recalled
Empatica Srl is recalling Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children, distributed nationwide in the US. The recall was initiated on 13 Jul 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0159-2024
- FDA event ID
- 93215
- Recalling firm
- Empatica Srl, Milan, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Jul 2023
- FDA classified
- 24 Oct 2023
- Reported
- 1 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 13 Jul 2023 | Recall initiated by company | |
| 24 Oct 2023 | Classified by FDA | +103 days |
| 1 Nov 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Italy, Ireland, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Germany, Finland, Netherlands, Poland, Sweden.
Questions about this recall
Is Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children recalled?
Yes. Empatica Srl recalled Embrace2- Indicated for use as an adjunct to seizure monitoring of adults and children on 13 Jul 2023. The recall is Class II and its status is Ongoing. Recall number Z-0159-2024.
Why was it recalled?
May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.
Which lots are affected?
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
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Italy, Ireland, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Germany, Finland, Netherlands, Poland, Sweden.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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