Draeger, Inc. recalls VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable brea…

Potential cracks in the hose, which could lead to leakage or the hose falling off.

VentStar Resus Neo. Neonatal. 25 Units per Box. Part Number: MP00310 Disposable breathing circuit for use with a resuscitation module.

Draeger notified consignees on about 09/03/2026 via emailed Urgent Medical Device Recall letter. Consignees were informed of the issue of a cracked hose and that currently there are no alternative products from other manufacturers that have been tested and approved by Draeger for use with these devices, nor are there substitute products available within the Draeger portfolio in the U.S. Consignees were instructed to carefully inspect the hoses for damages prior to use according to the product s Instructions for Use (IFU), discard products that show cracks or have a detached hose, inform all potential users within the facility, and if affected products have been transferred or distributed, to notify those customers. Additionally, customers were requested to complete and return the provided Medical Device Recall Return Response Acknowledgement and Receipt Form. Draeger will replace the affected circuits free of charge after a correction is implemented based on the quantity indicated on the Medical Device Recall Return Response Acknowledgement and Receipt Form.

• FDA enforcement recordOfficial FDA database entry for Z-3252-2026
• FDA 510(k) clearance · K092029The device's official FDA premarket clearance record
• FDA device classification · BYEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5965The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Draeger, 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.