FDA Recalled Draeger Breathing Hoses for Infants
A breathing hose used for infants weighing up to 22 lbs was recalled due to potential cracking and air leaks.
Updated on Oct. 2, 2026 in Babies
On September 3, 2026, the FDA classified a Class I recall of the Draeger VentStar Resus Neo breathing hose after reports of cracks in the product. These devices are intended for use in infants weighing up to 22 lbs.
Why it matters
The recall was initiated because cracks in the hoses may cause the device to leak or detach during use, which can restrict ventilation for vulnerable infants. Restricted airflow risks serious complications, including desaturation or hypoxia.
The FDA issued a Class I recall, the agency's most serious designation, following reports of cracked VentStar Resus Neo hoses. While there have been no documented serious injuries or deaths, the potential for device failure remains under investigation.
The players
Draeger
A medical technology company that manufactures critical care devices, including ventilation and respiratory equipment.
FDA
The federal agency responsible for overseeing the safety and efficacy of medical devices used in the United States.
The details
The VentStar Resus Neo is a breathing hose designed to provide respiratory support to infants. If the material cracks, the device can fail to deliver consistent air pressure or may disconnect entirely from the ventilation system. Clinicians are advised to inspect all inventory and immediately remove any hoses showing signs of wear or structural damage.
Timeline
September 3, 2026: Draeger issued official recall notices to its customers.
Health Landscape
This recall falls under the FDA Class I designation, reserved for products that carry a high probability of causing serious health consequences or death. It reflects the ongoing clinical priority of maintaining the structural integrity of neonatal respiratory support equipment.
If you are a caregiver or healthcare professional using the VentStar Resus Neo, ensure all units are inspected for cracks prior to use. Any concerns regarding device performance or alternative ventilation equipment should be discussed with your medical team.
The takeaway
The primary safety measure for this recall is the proactive inspection of all respiratory equipment for signs of physical degradation. If you have questions about specific devices in your care setting, you may contact Draeger at 445-224-0698 for further information.
Further reading
For broader guidance on managing infant care products, explore our Babies archive.
