{"url_path":"/fda/device/recalls/Z-2188-2026","section_key":"summary","section_title":"DEVICE Recall: Stryker Sustainability Solutions — Daig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-10","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2188-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Stryker Sustainability Solutions"},"word_count":79,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2188-2026\n\n**Recalling firm:** Stryker Sustainability Solutions\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-10\n**Report date:** 2026-05-20\n\n## Product\nDaig Livewire Steerable, Product Number 401582; REPROCESSED ELECTROPHYSIOLOGY CATHETER\n\n## Reason\nIncomplete seals on sterile product\n\n## Affected lots\nUDI 00885825006884, Lot Numbers:  3002664, 4092049, 4580888, 4627994, 4778840, 4860529, 4998452, 4026540, 4098358, 4620256, 4627999, 4813542, 4985859, 4072508, 4498128, 4620257, 4755333, 4860528, 4985861.\n\n## Distribution\nUS Nationwide and the countries of Israel and Canada."}