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U.S. Department of Health and Human Services

Medical Device Recalls
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18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, m... 1 11/15/2022 Insulet Corporation
SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological mo... 1 08/26/2015 Ethicon Endo-Surgery Inc
Shoulder Flex Massage Device Device is an electric personal massage device labeled in part: "Sho... 1 11/10/2011 King International
HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R, R5C8320, R5C... 1 03/01/2010 Baxter Healthcare Renal Div
Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471, 5C4471R, 5C4474, ... 1 03/01/2010 Baxter Healthcare Renal Div
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the fo... 2 08/03/2023 MEDLINE INDUSTRIES, LP - Northfield
ReWalk Personal 6.0, ReWalk Personal 5.0 and ReWalk R Systems orthotically fits to the lower limbs a... 2 05/11/2021 Argo Medical Technologies Ltd
CareLink Personal Software Therapy Management Software Tool for Diabetes CareLink System Therapy Ma... 2 01/11/2021 Medtronic Inc.
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1... 2 03/20/2020 Insulet Corporation
Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protect... 2 02/24/2020 Breas Medical, Inc.
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