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U.S. Department of Health and Human Services

Medical Device Recalls
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Z-0939-2024 - EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-0855 2 01/31/2024 FEI # 2429304
Olympus Corporation of the Americas
Z-0940-2024 - EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of strictures in the alimentary tract in adults and adolescents (>12 years) Model: BD-410X-1055 2 01/31/2024 FEI # 2429304
Olympus Corporation of the Americas
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