{"url_path":"/fda/device/recalls/Z-2172-2026","section_key":"summary","section_title":"DEVICE Recall: Edwards Lifesciences, LLC — Edwards EVOQUE tricuspid delivery system  REF:9850TDS  Sterile EO","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-03-27","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2172-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Edwards Lifesciences, LLC"},"word_count":119,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2172-2026\n\n**Recalling firm:** Edwards Lifesciences, LLC\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-03-27\n**Report date:** 2026-05-20\n\n## Product\nEdwards EVOQUE tricuspid delivery system  REF:9850TDS  Sterile EO\n\n## Reason\nLabeling update to provide warning if functionality of the  valve replacement delivery system is compromised.\n\n## Affected lots\nAll Lots/UDI:0690103D004EVD000V5\n\n## Distribution\nWorldwide - 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."}