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All product recalls associated with Edwards Lifesciences Corporation of Puerto Rico.
Total Recalls
1000
Past Year
1000
Class I (Serious)
34
Most Recent
Jan 2026
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.
Lot is being recalled because some of the kits contain an incorrect guidewire.
The product displays inaccurate temperature readings, patient skin burns can occur before getting to higher temperature reading.
Failure of foot pedal to activate device