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U.S. Department of Health and Human Services

Medical Device Recalls
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Optima XR200amx, Mobile Digital-Ready Radiographic System 2 07/13/2026 FEI # 2126677
GE Medical Systems, LLC
Optima XR240amx, Mobile Digital Radiographic System 2 07/13/2026 FEI # 2126677
GE Medical Systems, LLC
Optima XR220amx, Mobile Digital-Ready Radiographic System 2 07/13/2026 FEI # 2126677
GE Medical Systems, LLC
Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Inf... 1 07/10/2026 FEI # 1035166
Oscor Inc.
Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Inf... 1 07/10/2026 FEI # 1035166
Oscor Inc.
Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Inf... 1 07/10/2026 FEI # 1035166
Oscor Inc.
da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15 2 07/10/2026 FEI # 3001675293
Intuitive Surgical, Inc.
ABIOMED Impella CP Set, Pump Set Code 0048-0044; containing Introducer Product Code 0052-3046. hear... 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, S... 1 07/10/2026 FEI # 1220648
Abiomed, Inc.
ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introd... 1 07/10/2026 FEI # 1220648
Abiomed, Inc.

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