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U.S. Department of Health and Human Services

Medical Device Recalls
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P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm... 2 07/17/2026 FEI # 3008650117
Paragon 28, Inc.
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Car... 2 07/17/2026 FEI # 2124215
Boston Scientific Corporation
FARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac Ablation C... 2 07/17/2026 FEI # 2124215
Boston Scientific Corporation
FARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter 2 07/17/2026 FEI # 2124215
Boston Scientific Corporation
Power F2 Powered Fastening System, Product No. 0567091 Powered fastening system intended for profe... 2 07/17/2026 FEI # 1523574
Ferno-Washington Inc
Hotline Fluid Warming Set, single use device, is designed to warm blood and intravenous fluids and d... 2 07/17/2026 FEI # 3012307300
ICU Medical Inc.
FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Car... 2 07/17/2026 FEI # 2124215
Boston Scientific Corporation
ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testoster... 2 07/16/2026 FEI # 3005529799
Tosoh Bioscience Inc
Papablic Replacement Brush Heads. Model Number: PAPA317AA. 2 07/15/2026 FEI # 3045522789
Papablic Inc
Papablic Replacement Brush Heads. Model Number: Papablic18B 2 07/15/2026 FEI # 3045522789
Papablic Inc

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