- Recalling firm
- Edwards Lifesciences, LLC
- Reason for recall
- Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
- Distribution pattern
- Worldwide - US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Saudi Arabia, Germany, United Kingdom.
- State
- CA
- Status
- Ongoing
- Recall number
- Z-2172-2026
- Recall initiated
- March 27, 2026