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All product recalls associated with Edwards Lifesciences Corporation of Puerto Rico.
Total Recalls
2
Past Year
0
Class I (Serious)
0
Most Recent
Nov 2006
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Lack of Assurance of Sterility-Device packaging was manufactured with an incorrect lid that could compromise the sterility of the product.
Lot is being recalled because some of the kits contain an incorrect guidewire.