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# Early Alert on CooperSurgical Neonatal CPAP Ventilator
- URL: https://www.fdaweb.com/early-alert-on-coopersurgical-neonatal-cpap-ventilator/
- Published: 2026-08-24T12:00:00.000Z
- Updated: 2026-09-14T12:05:52.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161670

FDA has issued an [early alert](https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-ventilator-issue-coopersurgical?utm%5Fmedium=email&utm%5Fsource=govdelivery) about a potentially high-risk problem involving certain CooperSurgical INCA neonatal and infant nasal continuous positive airway pressure (CPAP) sets that may develop a loose connection between the tubing and nasal cannula. Earlier this month, the company sent affected customers a letter recommending that they stop using and distributing the affected products and segregate them for return.

If a loose connection is identified while the CPAP is being used, CooperSurgical recommends replacing the tubing with another tubing set or CPAP device. FDA says that iIf the problem is not detected, the connection may leak or the tubing may disconnect from the nasal cannula. This can cause a loss of CPAP pressure, potentially reducing the effectiveness of respiratory treatment and resulting in decreased oxygenation until the connection is restored.

The INCA nasal CPAP system is used to provide continuous positive airway pressure to newborn and infant patients who require respiratory support.