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U.S. Department of Health and Human Services

Medical Device Recalls
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Product Description
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Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS 1 08/14/2025 Baxter Healthcare Corporation
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Versi... 1 08/13/2025 Thoratec LLC
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 ... 1 08/13/2025 Thoratec LLC
Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator, Adult, Catalog Number: 52321100... 1 08/13/2025 Ambu Inc.
Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery... 1 08/08/2025 Boston Scientific Corporation
DreamStation Auto BiPAP. Non-Continuous Ventilator. 1 08/08/2025 Philips Respironics, Inc.
DreamStation Auto. Non-Continuous Ventilator. 1 08/08/2025 Philips Respironics, Inc.
DreamStation Auto CPAP. Non-Continuous Ventilator. 1 08/08/2025 Philips Respironics, Inc.
Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing. 1 08/06/2025 B BRAUN MEDICAL INC
Plum Duo Infusion System, List Number: 400020401 1 08/06/2025 ICU Medical, Inc.

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