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U.S. Department of Health and Human Services

Medical Device Recalls
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VistaSolution, physiological signal transmitter. A software graphical user interface for use by hea... 2 07/10/2020 Vitalconnect Inc.
Pediatric Adjustable Flange Tracheostomy Tube Cuffless 2 07/01/2020 Smiths Medical ASD Inc.
AC Powered hospital adjustable bed. 2 06/02/2020 Umano Medical, Inc.
Fifty-five (55) cm 8 Contact Extension Kit, part number M365NM3138550 - Product Usage: The Deep Bra... 2 05/26/2020 Boston Scientific Neuromodulation Corporation
Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen; Software version 02.00.00.0076 - ... 2 04/28/2020 Obalon Therapeutics Inc
Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and... 2 01/31/2020 Dexcom Inc
MICRO-PSD HDR, Catalog Number: PSD-HB5N - Product Usage: pre-calibrated PSD sensors are intended for... 2 12/19/2019 Angiodynamics, Inc.
MICRO-PSD Electron, Catalog Number: PSD-EE5N - Product Usage: pre-calibrated PSD sensors are intende... 2 12/19/2019 Angiodynamics, Inc.
OARtrac PLUS CLINICAL DETECTOR UNIT Catalog Number: OTS-V2-Plus - Product Usage: pre-calibrated PSD... 2 12/19/2019 Angiodynamics, Inc.
OARTRAC PROSTATE IMMOBILIZATION ENDORECTAL BALLOON DEVICE KIT, Catalog Number: ORB-60F - Product Us... 2 12/19/2019 Angiodynamics, Inc.

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