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U.S. Department of Health and Human Services

Medical Device Recalls
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Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Qualitative detection and d... 2 09/03/2021 Versea Diagnostics LLC
Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2,... 2 09/03/2021 Versea Diagnostics LLC
Merge Hemo, Software packages 10.2, 10.3, and 10.4 2 08/28/2021 Merge Healthcare, Inc.
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic... 2 08/10/2021 Covidien Llc
Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with t... 2 06/04/2021 CLINICAL LASERTHERMIA SYSTEMS AB
Tranberg MR Cannula, REF: 4013-05, Rx Only, Sterile EO - Product Usage: used with the Tranberg® MR I... 2 06/04/2021 CLINICAL LASERTHERMIA SYSTEMS AB
Tranberg Laser Applicator Non-cooled, 1.7mm/ 15G, 15 mm, Diffuser, 12 m, REF: 4017-02, Rx Only, Ster... 2 06/04/2021 CLINICAL LASERTHERMIA SYSTEMS AB
Assure COVID-19 IgG/IgM Rapid Test Device that include: 1) Pouch Label - FaStep Rapid Diagnostic T... 2 04/16/2021 AZURE BIOTECH INC
CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive device to... 2 03/19/2021 CAIRE DIAGNOSTICS INC
VITROS SARS-CoV-2 Antigen Reagent Pack - The VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Rea... 2 03/17/2021 Ortho-Clinical Diagnostics, Inc.

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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