FDAJuly 13, 2023device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
May have a battery life lasting less than the full 48 hours, requiring the device to be charged more frequently.
What to do
FDA enforcement status: Ongoing
Brands named
empatica srlempatica
UPCs
0085385800613300853858006140008538580061260085385800611900853858006102
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDA.155 CRUNCHY CANNOLI GLUTEN FREE intended use: DESSERT condition: shelf stable shelf life: 12 month type of packaging: box, 190g 6.70 oz - 20 packages per case LOT: 2523000012 - BEST BEFORE: 10/17/2026 firm name & address listed on label: MID DOLCIARIA SRL VIA CASALINI, 8 -95032 - BELPASSO (CT)2026-05-06
- FDACANNOLI SICILIANI intended use: DESSERT condition: shelf stable shelf life: 12 month type of packaging: box, Net wt. 240g 8.47 oz UPC: 8056093851380 firm name & address listed on label: MID DOLCIARIA SRL VIA CASALINI, 8 -95032 - BELPASSO (CT)2026-05-06
- FDAREF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile2024-09-24
- FDAHerniatome, 17G x 15cm, Lumbar Type, Model Number 50917452021-05-17
- FDAHerniatome, 17G x 15cm, Lumbar Type with with 20ga-30cm Introducer, Model Number 50917152021-05-17
- FDAHerniatome, 17G x 9cm, Cervical Type, Model Number 50917492021-05-17
- FDAOmnia Soft Tissue Punch is a dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel. Model:...2021-03-30
- FDAGood & Gather Four Cheese Gnocchi, Net Wt. 16 oz. (454g), Keep Frozen. Needs to be Fully Cooked. UPC 0 85239-10366 1 Product of Italy. Dist by Target Corporation, Minneapolis, MN 554032021-01-15
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