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Fda Class I

All articles tagged with #fda class i

healthcare1 month ago•14 min saved

Boston Scientific Discontinues Imager II Catheters After Tip Defect Recall

Boston Scientific is permanently discontinuing its Imager II Angiographic Catheters following a Class I recall triggered by a manufacturing defect that risks tip detachment. The FDA has classified the issue as the most serious type, citing potential for life-threatening embolisms. Although only two serious injuries have been reported, the company is removing all units from the market due to deviations from design specifications.

via MedTech Dive|

#boston-scientific #fda-class-i #healthcare

health-and-safety1 month ago•2 min saved

FDA Upgrades Whole Foods Dip Recall to Class I Amid Multistate Salmonella Crisis

The FDA has upgraded the recall of Whole Foods dips and salsas to Class I, its highest risk level, due to potential Salmonella contamination. The move follows a multistate outbreak linked to jalapeños supplied by Coast Citrus Distributors, which has sickened hundreds across the U.S. While no illnesses have been directly attributed to the Whole Foods products, the agency warns that consumption could cause serious health consequences or death.

via Delish|

#coast-citrus-distributors #fda-class-i #food-safety