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U.S. Department of Health and Human Services

Medical Device Recalls
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GE Panda iRES Warmer, Model/Catalog Numbers: 1) M1112198-01045518; 2) M1112198-01045579; 3) M... 2 09/20/2024 Wipro GE Healthcare Private Ltd.
GE Giraffe Warmer, Model/Catalog Number M1118179-01090979. Infant radiant warmers provide infrared h... 2 09/20/2024 Wipro GE Healthcare Private Ltd.
paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N 1 09/20/2024 Smiths Medical ASD Inc.
paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N 1 09/20/2024 Smiths Medical ASD Inc.
BioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02, 360-1080-03, 360-158... 2 09/20/2024 Argon Medical Devices, Inc
Custom Procedure Kit, REF: K12T-11077 2 09/20/2024 Merit Medical Systems, Inc.
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F) 2 09/20/2024 Merit Medical Systems, Inc.
Ingenia Ambition X - For use as a diagnostic device to obtain cross-sectional images, spectroscopic... 2 09/20/2024 Philips North America Llc
Ingenia Ambition S - For use as a diagnostic device to obtain cross-sectional images, spectroscopic ... 2 09/20/2024 Philips North America Llc
Ingenia 3.0T CX - For use as a diagnostic device to obtain cross-sectional images, spectroscopic ima... 2 09/20/2024 Philips North America Llc

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