Ventilator Recall: CooperSurgical Removes INCA Infant Nasal CPAP Sets
The affected products and recommendations for what to do with the devices below have not changed. This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
The FDA is aware that CooperSurgical has issued a letter to affected customers recommending certain ventilators be removed from where they are used or sold.
Affected devices:
| Device / Product Name | Part Number | Lot Codes | Product UDI |
|---|---|---|---|
| INCA Infant Nasal CPAP, Complete Set | 44-2707 | 550019722 | (01) 20888937009433 |
| INCA Infant Nasal CPAP, Complete Set | 44-2709 | 550031617 550033781 550031621 | (01) 60888937009448 |
| INCA Infant Nasal CPAP, Complete Set | 44-2710 | 550031615 550031616 550031620 550034760 | (01) 20888937009457 |
| INCA Infant Nasal CPAP, Complete Set | 44-2712 | 550031611 550031614 550033779 550031619 | (01) 20888937009464 |
| INCA Infant Nasal CPAP, Complete Set | 44-2715 | 550031618 550033780 550034763 | (01) 20888937009471 |
| INCA Neonatal Nasal CPAP, Replacement Set | 44-0712 | 550031624 | (01) 60888937009516 |
| INCA Neonatal Nasal CPAP, Replacement Set | 44-0707 | 550021057 | (01) 20888937009488 |
| INCA Neonatal Nasal CPAP, Replacement Set | 44-0709 | 550031623 | (01) 20888937009495 |
| INCA Neonatal Nasal CPAP, Replacement Set | 44-0715 | 550031625 | (01) 20888937009525 |
What to Do
Do not use affected product. Identify affected product, cease use and distribution, and return to CooperSurgical.
On August 11, CooperSurgical sent all affected customers a letter recommending the following actions:
- If the loose connection is recognized during the use of the CPAP, replace the tubing with another tubing or CPAP device.
- Stop further use or distribution and segregate affected product
- Notify relevant personnel in your facility who use these devices
- If any products have been forwarded to another facility, contact that facility and provide them with the firm’s notice
Reason for Recall
CooperSurgical stated the units from specific lots of the INCA Neonatal Nasal CPAP Complete Set and Replacement Set may exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use. If the loose connection is not detected during assembly and/or placement, the tubing may leak at the connection to the nasal cannula or disconnect from the nasal cannula. This can result in loss of CPAP pressure, which may reduce the effectiveness of treatment and lead to decreased oxygenation of the patient until connection is restored.
As of August 11, CooperSurgical has reported no serious injuries or deaths associated with this issue.
Device Use
The INCA Infant Nasal CPAP Assembly is a medical device designed to deliver continuous positive airway pressure (CPAP) to newborn and infant patients requiring respiratory support. The system consists of a clear, soft nasal cannula connected to two shapeable "Stay-Flex" tubes that maintain a fixed position to minimize patient movement and nasal trauma. The assembly includes built-in tubing adapters, an in-line pressure adapter, a knit cap with fixation straps, and a chin strap to manage air leaks and secure the circuit.
Contact Information
Customers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact CooperSurgical Recall Support Team at fieldaction@coopersurgical.com or 203-895-2789.
Additional FDA Resources
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
Timeline of Communication Updates
| Date | Actions |
|---|---|
| 09/18/2026 | The FDA updated this communication to inform the public that this issue has been classified as a Class I Recall. |
| 08/24/2026 | The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue. |