Which Infant and Neonatal Breathing Devices Were Recalled?

The recalls involve different products and different failure mechanisms. They should not be treated as a single defect.

CooperSurgical INCA Infant and Neonatal Nasal CPAP Sets

CooperSurgical recalled specific lots of its INCA Infant Nasal CPAP Complete Sets and Neonatal Nasal CPAP Replacement Sets after identifying a potential loose connection between the flexible tubing and nasal cannula.

According to the FDA, the connection can leak or disconnect during use. This can cause a loss of continuous positive airway pressure, reduce treatment effectiveness, and decrease the infant’s oxygenation until the connection is restored.

The FDA classified the recalls as Class I on September 18, 2026, the agency’s most serious recall classification. The FDA recall database currently identifies “device design” as the cause of the INCA recalls. CooperSurgical had reported no serious injuries or deaths associated with the issue as of August 11.

Medline Hudson RCI Neonatal and Infant Heated-Wire Breathing Circuits

Medline recalled affected Hudson RCI neonatal and infant heated-wire breathing circuits after receiving reports of sporadic failures involving an electrical connector at the Neptune humidifier.

The connector may show discoloration, melting, smoke, a burning odor, or other signs of localized thermal damage. If the humidifier’s safety system detects an electrical abnormality, it can stop power to the heated wire while respiratory gas continues flowing.

That distinction matters. The recall does not describe a complete loss of respiratory gas. Instead, continued use without proper heating and humidification can expose an infant to cold, dry gas and increased condensation in the circuit. The FDA identifies potential consequences including bronchospasm, thickened secretions, airway obstruction, inadvertent positive end-expiratory pressure, fluid entering the airway, increased oxygen consumption, and worsening respiratory distress.

The FDA classified the action as a Class II recall on September 1, 2026.

Draeger VentStar Resus Neo Breathing Circuits

Draeger recalled VentStar Resus Neo hoses after users detected cracks in some hoses before use.

According to the FDA, a cracked hose may leak or detach. That can restrict ventilation or delay therapy, potentially causing oxygen desaturation, hypoxia, or death. The VentStar Resus Neo delivers breathing gas to infants weighing up to 22 pounds.

The FDA classified the recall as Class I on October 2, 2026. Its recall database lists more than one million affected units in commerce.

Why Can a CPAP or Breathing Circuit Failure Be So Serious?

Continuous positive airway pressure, or CPAP, provides pressure that helps support a baby’s breathing. A loose or disconnected component can interrupt that pressure and reduce the respiratory support the infant is supposed to receive.

Breathing circuits serve a related but different function: they carry respiratory gas between equipment and the patient. Cracks, disconnections, obstructions, or heating and humidification failures can interfere with the treatment being delivered.

The recent recalls illustrate several distinct pathways to harm: reduced CPAP pressure, decreased oxygenation, ventilation restriction, hypoxia, airway obstruction, and worsening respiratory distress.

A recall does not establish that a particular device caused an infant’s injury. Determining causation requires reviewing the exact device involved, the child’s clinical condition, respiratory-support settings, oxygen saturation data, alarms, treatment response, and the timing of any deterioration.

Can an Infant Breathing Device Injury Involve Product Liability and Medical Malpractice?

Potentially. The legal investigation may extend beyond a single defendant.

A defective CPAP set or breathing circuit may support a medical device product liability claim against the manufacturer or other entities in the product’s distribution chain. Depending on the evidence and applicable law, that investigation may examine design, manufacturing, warnings, recall communications, and whether a known problem was adequately addressed.

The CooperSurgical recall is particularly notable because the FDA recall database currently identifies device design as the cause. For the Medline and Draeger recalls, the FDA databases currently state that the firms are still investigating the cause.

Separate questions can arise about the hospital or medical providers. For example, an investigation may examine whether a facility received a recall notice, whether it properly removed affected inventory, whether it appropriately inspected or assembled equipment, and how clinicians responded to oxygen desaturation, respiratory distress, equipment alarms, or other signs of deterioration.

Those facts could implicate medical negligence in addition to product liability, but a recall alone does not establish malpractice. The provider’s conduct must be evaluated independently. Similar issues involving recognition and response to apnea, bradycardia, and oxygen desaturation also arise in NICU monitoring failure cases.

What Evidence Matters After a Suspected Infant Breathing Device Failure?

When a newborn or infant suffers serious respiratory or neurological harm, identifying the exact equipment used can be critical. Relevant evidence may include:

• the manufacturer, model, lot number, and unique device identifier for the CPAP set or breathing circuit;
• the device itself and any removed tubing, connectors, or components if they still exist;
• ventilator or CPAP settings and respiratory-therapy records;
• oxygen saturation trends, bedside-monitor data, alarms, and event logs;
• nursing, physician, and respiratory-therapy notes documenting desaturation or respiratory deterioration;
• hospital purchasing records, recall notices, inventory records, and communications concerning the affected product; and
• records showing when the device was replaced, disconnected, inspected, or removed from service.

These records can help distinguish an underlying medical complication from a device failure, delayed clinical response, or combination of factors.

For infants who develop hypoxic or other serious neurological injuries, the investigation may also overlap with broader prenatal, birth, and neonatal injury issues.

What Should Parents Do If They Believe a Recalled Device Was Used?

Parents who are concerned about a device currently being used for their child should speak directly with the treating medical team rather than altering or disconnecting respiratory equipment themselves.

Families can ask the hospital to identify the manufacturer, product name, model, lot number, and UDI of the CPAP set or breathing circuit used during the child’s treatment. If an unexpected desaturation, hypoxic event, respiratory deterioration, or other serious injury occurred, preserving the medical and device records may become important to determining what happened.

The FDA also accepts reports of suspected medical-device problems through its MedWatch program.

When a Recalled Breathing Device May Have Contributed to Serious Harm

If your child suffered oxygen desaturation, hypoxia, respiratory distress, neurological injury, or another serious complication while receiving respiratory support through a recalled CPAP set or breathing circuit, the circumstances deserve careful investigation.

McEldrew Purtell evaluates catastrophic injuries involving defective products and medical devices as well as neonatal medical negligence. Determining what happened may require examining the recalled product, hospital recall response, device records, respiratory data, clinical monitoring, and the medical response to deterioration.

Affected families can contact McEldrew Purtell for a free consultation to discuss the circumstances and potential legal options.