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U.S. Department of Health and Human Services

Medical Device Recalls
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InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack... 2 11/28/2025 Enterix, Inc.
Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrilla... 2 11/28/2025 Medtronic, Inc.
Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Descr... 2 11/26/2025 Noah Medical Corporation
Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02 2 11/26/2025 DJO, LLC
FlexLab (FLX); Version: FLX-217-10; 2 11/26/2025 Inpeco S.A.
FlexLab (FLX); Version: FLX-217-40; 2 11/26/2025 Inpeco S.A.
IntelePACS - InteleConnect / TechPortal 2 11/26/2025 INTELERAD MEDICAL SYSTEMS INCORPORATED
Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: ... 2 11/26/2025 Mindray DS USA, Inc. dba Mindray North America
Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following:... 2 11/26/2025 Mindray DS USA, Inc. dba Mindray North America
IV Administration Set utilized in gravity IV administration sets and pump administration sets utiliz... 2 11/26/2025 B Braun Medical Inc

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