SunMed Holdings, LLC recalls Adult Manual Resuscitator with Medium Adult Mask

Affected lots were manufactured with B/V Filter incorrectly attached to the wrong port (patient port instead of the exhalation port). If not noticed prior to patient use, there would be interruption or delay in patient resuscitation, which may lead to life threatening consequences, including hypoxia, hypercapnia, organ failure, and death.

Recall initiated May 1, 2025. Customers instructed to immediately cease use of any affected product and quarantine all affected product. Customers were instructed to return or destroy affected product. AirLife will send new replacement product to customers once disposition is confirmed. If you need replacement products to be sent to you urgently, please call AirLife directly on 1-800-433-2797 and the firm will make every effort to accommodate your needs.

• FDA enforcement recordOfficial FDA database entry for Z-1814-2025
• FDA 510(k) clearance · K953546The device's official FDA premarket clearance record
• FDA device classification · BTMOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5915The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find SunMed Holdings, LLCSearch 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.