CooperSurgical, Inc. recalls INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP

Potential 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.

CooperSurgical notified consignees on about 08/11/2026 via "URGENT Medical Device Recall" letter. Consignees were notified of the issue and potential hazard, and were instructed to identify affected units on hand, if any loose connection is recognized during the use of the CPAP, replace the tubing with another tubing or CPAP device, and remove all product of the subject lots from inventory and note the number of units to be returned on the attached Recall Response Form that is provided. Distributors were instructed to remove all product of the subject lots from inventory and note the number of units to be returned on the attached Distributor Only Acknowledgement Form. Additionally, they were instructed to communicate the recall notification to all customers that they distributed these devices to.

• FDA enforcement recordOfficial FDA database entry for Z-3139-2026
• FDA 510(k) clearance · K911780The device's official FDA premarket clearance record
• FDA device classification · BZDOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5905The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find CooperSurgical, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.