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U.S. Department of Health and Human Services

Medical Device Recalls
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GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph 2 08/04/2026 FEI # 3012359877
GE Medical Systems Information Technologies Inc
Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000 2 08/04/2026 FEI # 3030187577
Happiest Baby, Inc
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL 3 08/04/2026 FEI # 1219913
Siemens Healthcare Diagnostics, Inc.
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592 2 08/04/2026 FEI # 3001570235
GE Medical Systems Information Technologies Inc
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL 3 08/04/2026 FEI # 2517506
Siemens Healthcare Diagnostics, Inc.
FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGD... 2 08/04/2026 FEI # 3010770794
Biofire Defense
Merge OrthoPACS, medical imaging diagnostic workstation 2 08/04/2026 FEI # 1000116130
Merge Healthcare, Inc.
Merge PACS, medical imaging diagnostic workstation 2 08/04/2026 FEI # 1000116130
Merge Healthcare, Inc.
Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Cat... 2 08/03/2026 FEI # 1030451
Medical Action Industries, Inc. 306
Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 68... 2 08/03/2026 FEI # 3002808128
Maquet Critical Care AB

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