FDA tells hospitals to inspect certain infant breathing circuits

The FDA is warning U.S. health care providers about a potentially high-risk problem involving certain disposable breathing circuits used with infants in critical and emergency care.

The agency posted an Early Alert on September 3, 2026, after Draeger sent affected customers a safety letter on September 1. The notice concerns the VentStar Resus Neo breathing circuit, model MP00310, with unique device identifier (UDI) 04048675422358.

Which device is affected

The VentStar Resus Neo is a disposable breathing circuit that conveys breathing gas from a source to infants weighing up to 22 pounds. The FDA notice identifies model MP00310 and the listed UDI; it does not say that all Draeger breathing circuits, all lots or every unit are affected.

The FDA described the action as an Early Alert, not a completed FDA recall. The agency said it is reviewing information about the potentially high-risk issue and will update the notice as significant new information becomes available.

What hospitals should do

Health care providers and other affected users should inspect the hoses before use, following the product’s Instructions for Use. Units should be removed from use if a hose shows visible cracks or has a detached section.

The FDA says damaged hoses should be discarded and do not need to be returned to Draeger unless the company separately provides other instructions. Facilities should also follow their own equipment-replacement and patient-safety procedures.

The alert is directed primarily to hospitals and other health care providers. Parents and caregivers should not try to inspect, replace or handle hospital respiratory equipment themselves. Questions about equipment being used during treatment should go to the treating facility.

Why a damaged hose matters

Draeger told the FDA that users had detected obvious cracks in some hoses before use. If a cracked hose is used, it could leak or come off, restricting ventilation or delaying therapy.

Those problems could reduce the amount of oxygen reaching a patient’s blood, a condition known as desaturation. More serious oxygen deprivation, known as hypoxia, can cause severe harm and, in the circumstances described by the FDA, could contribute to death.

The FDA is describing these as potential consequences if a damaged hose is used and the problem is not detected. The notice does not say that every unit is defective or that any patient experienced those outcomes.

What is known about injuries

As of August 27, 2026, Draeger had reported no serious injuries or deaths associated with the issue. The FDA’s review remains ongoing.

U.S. customers with adverse events, quality problems or questions about the issue may contact Draeger at 445-224-0698 or through the company contact listed in the FDA notice. Health care professionals and consumers may also report device problems to the FDA’s MedWatch program.

Hospitals should continue checking the FDA alert page for updates, including any later information about the scope of affected products or additional instructions.

Sources

• FDA: Early Alert — Breathing Circuit Issue from Draeger
• Medical Daily: Cracked Hoses in a Newborn Breathing Circuit

Look for updates to this story

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