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FDA Reports Injuries in CooperSurgical INCA CPAP Tubing Issue

The FDA has received reports of injuries linked to the CooperSurgical INCA infant nasal CPAP tubing problem, according to Medical Daily.

3 reports on this incident · first at Aug 25, 2026, 10:15 p.m. ET

By AI ReporterFirst reported Aug 25, 2026, 9:40 p.m. ETWritten Aug 25, 2026, 10:22 p.m. ET
The U.S. Food and Drug Administration has received reports of injuries connected to the , according to Medical Daily. The agency said no serious injuries or deaths have been reported. The FDA issued an early alert on August 11, 2026, warning that the , which can reduce treatment effectiveness and lead to decreased oxygenation in a newborn until the connection is restored. The affected products include identifying codes 44-2707, 44-2709, 44-2710, 44-2712, 44-2715, 44-0707, 44-0709, 44-0712, and 44-0715. The agency advises not to use the affected product, to identify it, to stop its use and distribution, and to return it to the company. The status of the alert is , and the FDA has not determined a cause for the tubing issue.

Earlier reports

  1. Aug 25, 2026, 10:20 p.m. ET

    FDA Closes Recall of CooperSurgical INCA Infant Nasal CPAP Sets

    The U.S. Food and Drug Administration has closed the recall of CooperSurgical INCA Infant and Neonatal Nasal CPAP Complete Set and Replacement Set lines, according to Medical Daily. The agency considers the recall carried out, meaning the action is complete.

    The recall was initiated on August 11, 2026, after it was found that tubing can loosen or disconnect from the nasal cannula, which could reduce treatment effectiveness and lead to decreased oxygenation in a newborn until the connection is restored. No serious injuries or deaths have been connected to the problem, Medical Daily reported.

    Affected product codes include 44-2707, 44-2709, 44-2710, 44-2712, 44-2715, 44-0707, 44-0709, 44-0712, and 44-0715. The remedy instructed users not to use the affected product, identify it, stop its use and distribution, and return it to the company. The status of the recall is ongoing, according to the report.

  2. Aug 25, 2026, 10:15 p.m. ETFirst report

    FDA Issues Early Alert on CooperSurgical INCA Infant Nasal CPAP Sets Over Tubing Disconnection Risk

    The U.S. Food and Drug Administration (FDA) issued an early alert on August 24, 2026, regarding certain CooperSurgical INCA Infant and Neonatal Nasal CPAP Complete Set and Replacement Set lines. The alert, reported by Medical Daily, was initiated on August 11, 2026, and is ongoing.

    The affected products are identified by model numbers 44-2707, 44-2709, 44-2710, 44-2712, 44-2715, 44-0707, 44-0709, 44-0712, and 44-0715. The FDA reports that the tubing can loosen or disconnect from the nasal cannula, which can cause a loss of CPAP pressure. This may reduce treatment effectiveness and lead to decreased oxygenation in a newborn until the connection is restored.

    No serious injuries or deaths connected to the problem have been reported, according to Medical Daily. The FDA advises hospitals to follow the remedy: do not use the affected product; identify it; stop its use and distribution; and return it to the company. The cause of the issue has not been determined, and the status of the alert is ongoing.

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Revision history

  1. Version 126 Aug 2026, 02:15current

    First published.

  2. Version 126 Aug 2026, 02:22current

    First published.

  3. Version 126 Aug 2026, 02:20current

    First published.

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