FDA Classifies CooperSurgical INCA Infant Nasal CPAP Recall as Class I
FDA has classified the recall of specified CooperSurgical INCA Infant and Neonatal Nasal CPAP sets as Class I because a loose connection between the Stay-Flex tubing and nasal cannula may cause loss of CPAP pressure and reduced oxygenation.
Decision support
Decision summary
Official recall information is separated from MedTech Current editorial analysis.
Official recall information
What happened
Specified INCA Infant Nasal CPAP Complete Sets and INCA Neonatal Nasal CPAP Replacement Sets may have a loose connection between the Stay-Flex tubing and nasal cannula during assembly or use. If the connection leaks or separates, CPAP pressure can be lost, reducing treatment effectiveness and decreasing patient oxygenation until the connection is restored. FDA classified the recall as Class I on September 18, 2026.
MedTech Current analysis
Why it matters
The affected products provide continuous positive airway pressure to newborn and infant patients who require respiratory support. A loss of pressure or oxygenation in this population can lead to serious injury or death, particularly when the problem is not recognized promptly. As of August 11, CooperSurgical had reported no serious injuries and no deaths associated with the issue.
Actions by role
MedTech Current analysis — editorial interpretation, not FDA-authored guidance.
- MedTech Current analysisManufacturers and suppliersverify lot traceability, connector inspection, complaint escalation, and downstream notification controls for comparable neonatal respiratory circuits.
- MedTech Current analysisHealthcare facilities and professionalsidentify affected lots, stop use and distribution, quarantine or return them as instructed, and ensure an alternative respiratory-support option is available if a loose connection is observed during use.
- MedTech Current analysisGeneral MedTech readersdistinguish FDA's official recall facts and CooperSurgical's instructions from these role-based operational interpretations.
Official recall information
Official actions
According to CooperSurgical's August 11 recall communication and FDA's recall database instructions:
- Identify and segregate affected products, stop further use and distribution, return affected products to CooperSurgical, and notify relevant personnel within the facility.
- If a loose connection is recognized while CPAP is in use, replace the tubing with another tubing or CPAP device.
- Distributors should remove affected lots from inventory, record units to be returned on the Distributor Only Acknowledgement Form, and notify customers that received the affected devices.
Detailed recall information
Detailed sourced information from the published Recall Brief follows.
What changed
CooperSurgical is removing specified INCA Infant Nasal CPAP Complete Sets and INCA Neonatal Nasal CPAP Replacement Sets because the Stay-Flex tubing may have a loose connection with the nasal cannula during assembly or use. If the connection leaks or separates, CPAP pressure can be lost, reducing treatment effectiveness and decreasing patient oxygenation until the connection is restored. FDA classified the recall as Class I on September 18, 2026.
The FDA first issued an Early Alert on August 24. According to the FDA communication, the INCA system provides continuous positive airway pressure to newborn and infant patients who require respiratory support. CooperSurgical had reported no serious injuries and no deaths associated with the issue as of August 11.
Who and what are affected
The recall covers specified lots of two INCA product groups. The complete set includes five affected part numbers, while the replacement set includes four.
| Product | Affected part numbers | FDA recall number |
|---|---|---|
| INCA Infant Nasal CPAP, Complete Set | 44-2707, 44-2709, 44-2710, 44-2712, 44-2715 | Z-3139-2026 |
| INCA Neonatal Nasal CPAP, Replacement Set | 44-0707, 44-0709, 44-0712, 44-0715 | Z-3140-2026 |
Only specified lots are affected; the primary FDA notice provides the complete lot and UDI list.
The FDA recall database identifies CooperSurgical, Inc. as the recalling firm. For Z-3139-2026, FDA lists 2,643 boxes, or 13,215 units, in commerce. For Z-3140-2026, FDA lists 149 boxes, or 745 units. Distribution included multiple U.S. states as well as Brazil and Peru.
What affected organizations should do
Affected customers
According to CooperSurgical’s August 11 recall communication:
- Identify and segregate affected products.
- Stop further use and distribution of affected products.
- Return affected products to CooperSurgical.
- Replace the tubing with another tubing or CPAP device if a loose connection is recognized while CPAP is in use.
- Notify relevant personnel within the facility who use the devices.
- Provide CooperSurgical’s recall notice to another facility if affected products were forwarded there.
- Complete the applicable Recall Response Form.
Distributors
According to the FDA recall database:
- Remove affected lots from inventory.
- Record the number of units to be returned on the Distributor Only Acknowledgement Form.
- Notify all customers that received the affected devices.