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U.S. Department of Health and Human Services

Medical Device Recalls
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CODMAN Disposable Perforator 9mm. Cranial Perforator. 1 11/03/2025 Integra LifeSciences Corp. (NeuroSciences)
Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Andro... 1 10/30/2025 Dexcom, Inc.
IMRIS Operating Suite, IMRIS iMRI 3T V, containing Siemens 3 Tesla MRI Magnet, vIDA 1 10/28/2025 IMPRIS Imaging Inc
IMRIS Operating Suite, iMRI 3T S, containing Siemens 3 Tesla MRI Magnet, Skyra 1 10/28/2025 IMPRIS Imaging Inc
IMRIS Operating Suite, Neuro III-SV iMRI System, iMRX System, containing Siemens 3 Tesla MRI Magnet... 1 10/28/2025 IMPRIS Imaging Inc
IMRIS Operating Suite, InVision 3T Operating Suite, containing Siemens 3 Tesla MRI Magnet, Vida 1 10/28/2025 IMPRIS Imaging Inc
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: M... 1 10/24/2025 BALT USA, LLC
IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w/Clave, Luer Lock, REF:... 1 10/23/2025 ICU Medical, Inc.
Brand Name: Hemodialysis Bloodlines Product Name: STREAMLINE BLOODLINE SET FOR DIALOG Model/Catalo... 1 10/22/2025 B BRAUN MEDICAL INC
Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AI... 1 10/17/2025 Abiomed, Inc.

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