{"url_path":"/fda/device/recalls/Z-1935-2026","section_key":"summary","section_title":"DEVICE Recall: Cook Incorporated — Aurous Centimeter Sizing Catheter  RPN N5.0-35-100-P-10S-PIG-CSC-20-01  GPN G47308    Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-02","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1935-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Cook Incorporated"},"word_count":157,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-1935-2026\n\n**Recalling firm:** Cook Incorporated\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-02\n**Report date:** 2026-05-13\n\n## Product\nAurous Centimeter Sizing Catheter  RPN N5.0-35-100-P-10S-PIG-CSC-20-01  GPN G47308    Sizing catheters are single-use, sterile catheters with gold marker bands. These catheters are for use in angiographic procedures and available in a variety of lengths (70 and 100 cm) and tip configurations (straight, PIG, and VCF).\n\n## Reason\nMarker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.\n\n## Affected lots\nUDI-DI 00827002473089 Lots 16858459 16869145 16857138 16763324 16750208 16752733 16821053 16713191\n\n## Distribution\nUS distribution nationwide. OUS distribution to Brunei, Brazil, Canda, China, Colombia, Costa Rica, Hong Kong, Israel, India, Japan, South Korea, Macau, New Zealand, Singapore, El Salvador, Taiwan, Uruguay"}