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U.S. Department of Health and Human Services

Medical Device Recalls
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5-PLASMA Bivalirudin AMR Verification Kit, Model Number 5D-45905 2 08/05/2026 FEI # 3005017664
Aniara Diagnostica LLC
HardyDisk AST Cefiderocol 30®g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30®g (FDC30) for in ... 2 08/05/2026 FEI # 2022807
Hardy Diagnostics
Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-... 2 08/05/2026 FEI # 1000395711
United Orthopedic Corp.
Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 M... 2 08/05/2026 FEI # 1000395711
United Orthopedic Corp.
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalo... 2 08/05/2026 FEI # 1000395711
United Orthopedic Corp.
Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left a... 2 08/05/2026 FEI # 1000395711
United Orthopedic Corp.
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM... 1 08/05/2026 FEI # 3006630150
Boston Scientific Neuromodulation Corporation
GE Healthcare MAC VU360, REF# part number 2030361-023; Electrocardiograph 2 08/04/2026 FEI # 3012359877
GE Medical Systems Information Technologies Inc
Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000 2 08/04/2026 FEI # 3030187577
Happiest Baby, Inc
Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No. 7C219UL 3 08/04/2026 FEI # 1219913
Siemens Healthcare Diagnostics, Inc.

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