{"url_path":"/fda/device/recalls/Z-2195-2026","section_key":"summary","section_title":"DEVICE Recall: Stryker Sustainability Solutions — Daig Livewire Steerable, Product Number 401915; 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-2195-2026%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":253,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2195-2026\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 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER\n\n## Reason\nIncomplete seals on sterile product\n\n## Affected lots\nUDI 00885825007300, Lot Numbers:  1772607, 3994138, 4539200, 4808444, 4985924, 5010522, 5042942, 2482952, 4046485, 4539206, 4808677, 4986242, 5010524, 5042944, 2521570, 4164020, 4540476, 4812775, 4986243, 5017909, 5042945, 2521636, 4166570, 4544644, 4817888, 4986244, 5018848, 5043881, 2521660, 4182322, 4549452, 4824089, 4986245, 5020135, 5043883, 2577590, 4183176, 4549458, 4824092, 4986256, 5020136, 5052391, 2711877, 4206584, 4549460, 4824093, 4986399, 5020139, 5056580, 2769403, 4216286, 4551863, 4825561, 4993904, 5020147, 5060152, 2769695, 4247577, 4567736, 4830114, 4993905, 5020149, 5060153, 2787951, 4260013, 4569285, 4833151, 4993910, 5020453, 5060154, 2919616, 4274184, 4569297, 4850593, 4993912, 5024412, 5060155, 2919619, 4275872, 4569532, 4854631, 4993914, 5024413, 5060156, 2919623, 4287229, 4569539, 4854632, 4993915, 5025667, 5060157, 2986771, 4295030, 4577350, 4861162, 4993916, 5029412, 5060158, 3186438, 4390731, 4579539, 4861163, 4993920, 5032327, 5060159, 3269091, 4414236, 4665004, 4861164, 4997912, 5032328, 5060160, 3364168, 4414244, 4671456, 4868220, 4999701, 5032329, 5080121, 3371014, 4461334, 4675658, 4890809, 4999901, 5032330, 5080812, 3371015, 4477262, 4677973, 4950295, 5001378, 5032331, 5081406, 3371464, 4487544, 4734148, 4972469, 5001380, 5033613, 5081407, 3372123, 4487545, 4735713, 4974049, 5003013, 5035986, 5085275, 3398046, 4495634, 4739300, 4974050, 5003014, 5038644, 5085394, 3411209, 4508984, 4748755, 4976259, 5003015, 5038647, 5085395, 3413279, 4539190, 4756237, 4976293, 5003016, 5041264, 5085396, 3469626, 4539191, 4771668, 4985775, 5003017, 5042936, 5085889, 3499568, 4539192, 4792718, 4985776, 5003018, 5042937, 3784873, 4539196, 4804384, 4985921, 5003019, 5042940, 3896863, 4539199, 4808394, 4985922, 5008867, 5042941.\n\n## Distribution\nUS Nationwide and the countries of Israel and Canada."}