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U.S. Department of Health and Human Services

Medical Device Recalls
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BATTERY FLEX-3S2P 10.8V 18650 LI-ION SMBUS used with affected patient monitors Model No 2062895-... 2 11/07/2025 GE Healthcare Finland Oy
Portrait VSM Model nos. 6660000-666 Monitor, Physiological, Patient (With Arrhythmia Detection... 2 11/07/2025 GE Healthcare Finland Oy
CARESCAPE ONE, Model no. 2087075-300 - shipped with potentially affected batteries or affected batte... 2 11/07/2025 GE Healthcare Finland Oy
B105P, B125P, B105M, B125M, B155M Patient Monitors; Model nos. 6160000-002 6160000-003 6160000-0... 2 11/07/2025 GE Healthcare Finland Oy
Virata Preassembled Polyaxial Screw, utilized in the Virata Spinal Fixation System. The following si... 2 11/07/2025 Orthofix U.S. LLC
BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000; 2 11/07/2025 Miach Orthopaedics
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic 2 11/06/2025 B-K Medical A/S
bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulsed Doppler, Ultrasonic 2 11/06/2025 B-K Medical A/S
bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulsed Doppler, Ultrasonic 2 11/06/2025 B-K Medical A/S
UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imaging, Pulsed Doppler, Ultr... 2 11/06/2025 B-K Medical A/S

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.
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