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U.S. Department of Health and Human Services

Medical Device Recalls
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AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material... 3 08/18/2022 Siemens Medical Solutions USA, Inc
ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000 3 07/25/2022 Zeiss, Carl Inc
Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD 3 07/20/2022 Randox Laboratories Ltd.
Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. IVD 3 07/20/2022 Randox Laboratories Ltd.
NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name ... 3 07/18/2022 Synapse Biomedical Inc
Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determin... 3 07/15/2022 R & D Systems, Inc.
GreenLight HPSEA Laser Fibers, UPN 0010-2092 3 07/15/2022 Boston Scientific Corporation
Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6 3 07/15/2022 Stryker Instruments Div. of Stryker Corporation
Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K589911-2 Anti-FITC-AP CISH Acc... 3 07/14/2022 Agilent Technologies, Inc.
HAMILTON-H900 Humidifier, Models: 950001, 950004 3 07/14/2022 Hamilton Medical AG

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