Cracks in disposable infant breathing hoses could cause restricted ventilation, hypoxia, or death, prompting the agency’s most serious recall designation.

The US Food and Drug Administration (FDA) has classified Draeger’s recall of certain VentStar Resus Neo disposable breathing circuits as a Class I recall, the agency’s most serious category, citing the risk of serious injury or death if affected devices continue to be used.

The recall involves the VentStar Resus Neo, model MP00310, with UDI 04048675422358. The device is a disposable breathing circuit used to convey breathing gas from a source to an infant weighing up to 22 lbs.

The FDA issued an Early Alert on Sept 3, 2026, notifying the public of the potentially high-risk device issue, and updated the communication on Oct 2, 2026, to confirm the Class I classification.

Reason the Recall

Draeger reported that users detected obvious cracks in the hose of the VentStar Resus Neo prior to use in multiple cases. If a cracked hose is used, it may fall off or leak, resulting in restricted ventilation or delayed therapy that could lead to desaturation, hypoxia, or patient death.

As of Sept 3, 2026, Draeger has reported no serious injuries or deaths associated with the issue.

On Sept 3, Draeger sent a letter to all affected customers recommending that users carefully inspect the hoses for damage prior to use, in accordance with the product’s Instructions for Use. Any products showing cracks or a detached hose should be discarded, and customers are not required to return affected devices to Draeger.

Because the devices are used in critical and emergency situations, the FDA is urging users to inspect and remove affected product prior to use.

Customers in the US with adverse reactions, quality problems, or questions about the issue can contact Draeger at 445-224-0698 or [email protected]. Adverse reactions or quality problems may also be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.