Edwards Lifesciences, LLC recalls

All Edwards Lifesciences, LLC recalls we track from FDA, CPSC and NHTSA data. Categories: medical devices (7).

7 recalls published between July 16, 2025 and May 20, 2026. 6 were FDA Class I, the most serious level.

• Edwards EVOQUE tricuspid delivery system recall
  FDA May 20, 2026 · Edwards Lifesciences, LLC · Class II
• FEM-FLEXII Product Name: Femoral Arterial Cannula Model recall
  FDA July 16, 2025 · Edwards Lifesciences, LLC · Class I
• FEM-FLEX II Product Name: Femoral Arterial Cannula Model recall
  FDA July 16, 2025 · Edwards Lifesciences, LLC · Class I
• FEM-FLEX II Product Name: Femoral Arterial Cannula Model recall
  FDA July 16, 2025 · Edwards Lifesciences, LLC · Class I
• FEM-FLEX II Product Name: Femoral Arterial Cannula Model recall
  FDA July 16, 2025 · Edwards Lifesciences, LLC · Class I
• Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model recall
  FDA July 16, 2025 · Edwards Lifesciences, LLC · Class I
• Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model recall
  FDA July 16, 2025 · Edwards Lifesciences, LLC · Class I