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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-0933-2024 - EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years).
Model: BD-400P-0880
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2
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01/31/2024
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Olympus Corporation of the Americas
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Z-0934-2024 - EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years).
Model: BD-400P-1080
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2
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01/31/2024
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Olympus Corporation of the Americas
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Z-0935-2024 - EZDilate Fixed Wire Balloon 11-12-13. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years).
Model: BD-400P-1380
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2
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01/31/2024
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Olympus Corporation of the Americas
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Z-0936-2024 - EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years).
Model: BD-400P-1580
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2
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01/31/2024
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Olympus Corporation of the Americas
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Z-0937-2024 - EZDilate Fixed Wire Balloon 16-17-18. Indicated for endoscopic dilation of strictures of the esophagus in adults and adolescents (>12 years).
Model: BD-400P-1880
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2
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01/31/2024
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Olympus Corporation of the Americas
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Z-0944-2024 - EZDilate Wire Guided Balloon 18-19-20. Indicated for endoscopic
dilation of strictures in the alimentary tract in adults and adolescents (>12 years).
Model: BD-410X-2055
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2
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01/31/2024
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Olympus Corporation of the Americas
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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
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2
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01/31/2024
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Olympus Corporation of the Americas
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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
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2
|
01/31/2024
|
Olympus Corporation of the Americas
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Z-0941-2024 - EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic
dilation of strictures in the alimentary tract in adults and adolescents (>12 years).
Model: BD-410X-1355
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2
|
01/31/2024
|
Olympus Corporation of the Americas
|
Z-0942-2024 - EZDilate Wire Guided Balloon 13.5-14.5-15.5. Indicated for endoscopic
dilation of strictures in the alimentary tract in adults and adolescents (>12 years).
Model: BD-410X-1555
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2
|
01/31/2024
|
Olympus Corporation of the Americas
|