{"url_path":"/fda/device/recalls/Z-3139-2026","section_key":"summary","section_title":"DEVICE Recall: CooperSurgical, Inc. — INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-08-11","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3139-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"CooperSurgical, Inc."},"word_count":177,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3139-2026\n\n**Recalling firm:** CooperSurgical, Inc.\n**Classification:** Class I\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-08-11\n**Report date:** 2026-09-30\n\n## Product\nINCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715.\n\n## Reason\nPotential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.\n\n## Affected lots\n1. Model Number: 44-2707. UDI-DI: (01)20888937009433. Lot Code: 550019722.   2. Model Number: 44-2709. UDI-DI: (01)60888937009448. Lot Codes: 550031617, 550033781, 550031621.   3.  Model Number: 44-2710. UDI-DI: (01)20888937009457. Lot Codes: 550031615, 550031616, 550031620, 550034760.   4.  Model Number: 44-2712. UDI-DI: (01)20888937009464. Lot Codes: 550031611, 550031614, 550033779, 550031619.   5.  Model Number: 44-2715. UDI-DI: (01)20888937009471. Lot Codes: 550031618, 550033780, 550034763.\n\n## Distribution\nNationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru."}