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U.S. Department of Health and Human Services

Medical Device Recalls
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Exactech Ergo Impactor Handle, Catalog #321-09-05. 2 06/30/2023 Exactech, Inc.
Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; ... 2 05/30/2023 Elekta, Inc.
Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which ... 2 04/18/2023 Boston Scientific Corporation
Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitori... 2 04/04/2023 Moberg Research, Inc.
Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-eme... 2 03/15/2023 Stryker Medical Division of Stryker Corporation
Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Pla... 2 03/14/2023 Securitas Healthcare LLC
MultiLab Series II LHS TI & ERGO non-invasive vascular diagnostic device, Model Number 11949-0000-01 2 03/01/2023 Unetixs Vascular, Inc.
IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyz... 2 01/11/2023 Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyz... 2 01/11/2023 Siemens Healthcare Diagnostics, Inc.
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Numb... 2 12/15/2022 Siemens Healthcare Diagnostics, Inc.

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