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The FDA classified Draeger’s recall of certain VentStar Resus Neo breathing circuits as Class I, its most serious recall category. Draeger advised affected customers to inspect hoses before use and discard any showing cracks or a detached hose; the FDA says no serious injuries or deaths had been reported as of September 3, 2026.
The U.S. Food and Drug Administration has classified Draeger’s recall of certain VentStar Resus Neo breathing circuits as a Class I recall, the agency’s most serious recall category. The FDA says a cracked or detached hose could leak or come loose during use, restricting ventilation or delaying therapy for an infant; it reported no serious injuries or deaths associated with the issue as of September 3, 2026.
The FDA’s October 2 update says the affected products and instructions have not changed since its September 3 alert. Draeger sent affected customers a letter recommending that users carefully inspect the hoses before use, following the device’s instructions for use. Any product with cracks or a detached hose should be discarded; customers do not need to return those devices to Draeger.
The identified product is the VentStar Resus Neo, model MP00310, with UDI 04048675422358. It is a disposable breathing circuit that conveys breathing gas from a source to an infant weighing up to 22 pounds. The FDA says the devices are used in critical and emergency situations.
Draeger told the FDA it was aware of cases in which users detected obvious cracks before using the hose. The agency warns that using a cracked hose could cause it to fall off or leak, potentially restricting ventilation or delaying therapy. Possible outcomes listed by the FDA include desaturation, hypoxia or patient death. These are stated risks, not reported outcomes in this recall; the FDA said Draeger had reported no serious injuries or deaths as of September 3.
Risks During Infant Emergency Ventilation
The recall concerns equipment used to deliver breathing gas to infants, including in critical and emergency care. A hose that leaks or separates could interfere with ventilation at a time when clinicians need the circuit to deliver gas as intended. The FDA’s Class I designation signals that the agency considers continued use of affected devices capable of causing serious injury or death.
The immediate action is a visual inspection before use and removal from use of any hose with visible damage. The FDA’s notice does not say that every affected hose is defective, nor does it report serious harm so far. It does identify a specific failure mode and advises customers not to use products that show cracks or detachment.
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September Alert, October Classification
The FDA issued an Early Alert on September 3, 2026, notifying the public about the potentially high-risk device issue and describing Draeger’s customer instructions. On October 2, the agency updated that communication to say the issue had been classified as a Class I recall. The FDA states that the affected products and recommended actions remained unchanged in the update.
The recall notice directs U.S. customers with questions, adverse reactions or quality concerns to contact Draeger at 445-224-0698 or karina.howard@draeger.com. Health professionals and consumers may also report adverse reactions or quality problems through the FDA’s MedWatch reporting program, according to the agency.
“Draeger stated that they are aware of cases in which obvious cracks in the hose of the VentStar Resus Neo were detected by users prior to use.”
— Draeger, as reported by the FDA
disposable neonatal resuscitation circuit
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Defect Scope and Reports Still Unknown
The FDA notice does not state how many circuits are affected, how many have been distributed, or how many cracked or detached hoses have been found. It also does not provide a lot-number range or other detailed identification limits beyond the product name, model and UDI. The notice says to inspect affected products but does not quantify the proportion that may be damaged.
The injury status is specific to the date reported: Draeger had reported no serious injuries or deaths as of September 3, 2026. The notice does not give a later tally or say whether additional cases have been reported since then. It also does not describe a replacement supply or a timetable for further updates.
ventilation circuit inspection tools
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Inspect Units and Follow FDA Updates
Customers with the identified VentStar Resus Neo circuit should follow Draeger’s letter and the product instructions for use, checking each hose for damage before use. Products with visible cracks or a detached hose should be discarded, not returned, according to the FDA’s summary. Customers who need clarification can contact Draeger using the phone number or email in the notice.
Health professionals and consumers can report quality issues or adverse events to FDA MedWatch. The FDA may update its communication as more information becomes available; the current notice does not announce a new deadline or a further scheduled action.
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Key Questions
Which Draeger product is involved?
The notice covers the VentStar Resus Neo disposable breathing circuit, model MP00310, UDI 04048675422358.
What should users do with an affected hose?
Inspect it before use according to the product instructions. Draeger recommends discarding any hose with cracks or a detached hose; the FDA says it does not need to be returned to Draeger.
Why did the FDA classify the recall as Class I?
The FDA says a cracked hose could fall off or leak, restricting ventilation or delaying therapy. The agency identifies possible risks including desaturation, hypoxia and death, which underlie the serious classification.
Have injuries or deaths been reported?
The FDA said Draeger had reported no serious injuries or deaths as of September 3, 2026. The notice does not provide a later count.
Who can customers contact with questions?
U.S. customers can contact Draeger at 445-224-0698 or karina.howard@draeger.com. Adverse reactions or quality problems may also be reported to FDA MedWatch.
Source: primary
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