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U.S. Department of Health and Human Services

Medical Device Recalls
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SeaSpine Polyaxial Head REF Number: 41-3010 2 07/20/2026 FEI # 3012120772
SEASPINE ORTHOPEDICS CORPORATION
Halyard EYE PACK. Model/Catalog Number: LVEY27 Convenience kit. 2 07/20/2026 FEI # 1047429
AVID Medical, Inc.
FARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and into the cham... 2 07/20/2026 FEI # 2124215
Boston Scientific Corporation
FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the cham... 2 07/20/2026 FEI # 2124215
Boston Scientific Corporation
FARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into the chambers... 2 07/20/2026 FEI # 2124215
Boston Scientific Corporation
FARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and into the c... 2 07/20/2026 FEI # 2124215
Boston Scientific Corporation
Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit d... 2 07/20/2026 FEI # 2429304
Olympus Corporation of the Americas
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 PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation Catheter 2 07/17/2026 FEI # 2124215
Boston Scientific Corporation

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