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U.S. Department of Health and Human Services

Medical Device Recalls
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Philips Lumify Diagnostic Ultrasound System 1 10/16/2026 FEI # 3019216
Philips Ultrasound, LLC
Think Surgical Square Driver REF: 109126 2 10/16/2026 FEI # 3000719653
Think Surgical, Inc.
B Braun SAFSITE Injection Site, RV1000NC SAFSITE VALVE W/O EXTRA CAP. Catalog Number: 415068. 2 10/16/2026 FEI # 2521402
B Braun Medical Inc
Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, Rxonly 2 10/16/2026 FEI # 1000517638
Medtronic Navigation, Inc.
Medtronic NDI Passive Spheres REF: 8801074, Sterile EO, 4/Tray 12 Pk., Rxonly 2 10/16/2026 FEI # 1000517638
Medtronic Navigation, Inc.
Medtronic NDI Passive Spheres REF: 8801071, Sterile EO, 1/Tray 12 pk., Rxonly 2 10/16/2026 FEI # 1000517638
Medtronic Navigation, Inc.
Medtronic NDI Passive Spheres REF: 8801075, Sterile EO, 5/Tray 12 Pk., Rxonly 2 10/16/2026 FEI # 1000517638
Medtronic Navigation, Inc.
Philips Smart-hopping 2.0 AP 1.4 GHz; Product/Model Number: 867216; 2 10/16/2026 FEI # 3006648320
Philips North America
PNE Lead Implant Kit REF: 1701 2 10/16/2026 FEI # 3002968685
Axonics, Inc.
Amplatzer Amulet Left Atrial Appendage Occluder Model Numbers 1. 9-ACP2-007-016 2. 9-ACP2-007-0... 2 10/16/2026 FEI # 3005334138
Abbott

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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