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U.S. Department of Health and Human Services

Medical Device Recalls

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The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a mobile assembly of elec... 2 02/07/2025 Ithera Medical Gmbh
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3)... 2 02/07/2025 CareFusion 303, Inc.
Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i... 1 02/07/2025 Getinge Usa Sales Inc
UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 036137202... 2 02/07/2025 Medicrea International
(1) Pyxis MedStation ES, Catalog No. 323; (2) Pyxis Anesthesia Station (PAS), Catalog No. 327; (3)... 2 02/07/2025 CareFusion 303, Inc.
MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 m... 2 02/07/2025 MICROVENTION INC.
Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic ins... 2 02/06/2025 Beckman Coulter, Inc.
Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK ... 2 02/06/2025 US Endodontics, LLC
IntelliVue Patient Monitor MX400. Model Number: 866060 2 02/05/2025 Philips North America Llc
IntelliVue Patient Monitor MX450. Model Number: 866062 2 02/05/2025 Philips North America Llc

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