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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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HemosIL SynthAFax. Partial Thromboplastin Time Tests. 3 12/17/2025 FEI # 1217183
Instrumentation Laboratory
Cardiosave Hybrid 3 12/16/2025 FEI # 3001418283
Datascope Corp.
Cardiosave Rescue 3 12/16/2025 FEI # 3001418283
Datascope Corp.
Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog ... 3 12/11/2025 FEI # 2183449
Orthofix U.S. LLC
Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: ... 3 12/11/2025 FEI # 2183449
Orthofix U.S. LLC
Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/... 3 12/11/2025 FEI # 2183449
Orthofix U.S. LLC
Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Numb... 3 12/11/2025 FEI # 2183449
Orthofix U.S. LLC
Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Ca... 3 12/11/2025 FEI # 2183449
Orthofix U.S. LLC
Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38... 3 12/11/2025 FEI # 2183449
Orthofix U.S. LLC
OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor... 3 11/17/2025 FEI # 1000119795
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC

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