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U.S. Department of Health and Human Services

Medical Device Recalls
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Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Softw... 2 08/06/2026 FEI # 3021453307
TISSIUM SA
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic 2 08/05/2026 FEI # 2432235
Siemens Healthcare Diagnostics, Inc.
REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments: - ... 2 08/05/2026 FEI # 2050012
Beckman Coulter Inc.
REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following in... 2 08/05/2026 FEI # 2050012
Beckman Coulter Inc.
Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic... 2 08/05/2026 FEI # 3042175844
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurio... 2 08/05/2026 FEI # 3042175844
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura under the following System Descriptions and corresponding model numbers: 1. Allura ... 2 08/05/2026 FEI # 3042175844
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905 2 08/05/2026 FEI # 3005017664
Aniara Diagnostica LLC
5-PLASMA Bivalirudin Control, Model Number 5D-44905 2 08/05/2026 FEI # 3005017664
Aniara Diagnostica LLC
5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905 2 08/05/2026 FEI # 3005017664
Aniara Diagnostica LLC

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