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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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FDA Recall
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Recalling Firm
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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.
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 1 10/16/2025 Olympus Corporation of the Americas
BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 1 10/16/2025 Olympus Corporation of the Americas
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180 1 10/16/2025 Olympus Corporation of the Americas
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC 1 10/16/2025 Olympus Corporation of the Americas
EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 1 10/16/2025 Olympus Corporation of the Americas
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2 1 10/16/2025 Olympus Corporation of the Americas

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