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U.S. Department of Health and Human Services

Medical Device Recalls
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Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U 1 06/03/2024 ARROW INTERNATIONAL Inc.
IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the trea... 2 06/03/2024 Ion Beam Applications S.A.
Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, F... 1 05/31/2024 Getinge Usa Sales Inc
Arial mobile application, model numbers 54640, 54630, and 54630-SMA, that utilizes Apple iOS 17.4 a... 2 05/31/2024 Securitas Healthcare LLC
LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Ti... 2 05/31/2024 CORENTEC CO., LTD
LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description... 2 05/31/2024 CORENTEC CO., LTD
The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in s... 2 05/31/2024 Stryker Neurovascular
The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable tip and are availab... 2 05/31/2024 Stryker Neurovascular
The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diam... 2 05/31/2024 Stryker Neurovascular
WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruc... 2 05/31/2024 WAVi Co.

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