CooperSurgical INCA Infant Nasal CPAP Sets
The INCA Infant Nasal CPAP Complete Set may have a loose tubing connection, causing loss of pressure and reduced oxygenation.
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
What happened
CooperSurgical, Inc., of Trumbull, Connecticut, recalled its INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP Complete Set and Neonatal Nasal CPAP Replacement Set, both with Stay-Flex tubing, because the flexible tubing may have a loose connection to the nasal cannula during assembly or use, which may result in loss of CPAP pressure and possibly reduce treatment effectiveness, leading to decreased oxygenation until the connection is restored.
The recall began August 11, 2026, and was added to the FDA's Enforcement Report on September 18, 2026, with nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA, and international distribution to Brazil and Peru.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI and model code are listed under that product.
INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box.
- UDI-DI
- 60888937009516
- 550031624
- 20888937009488
- 550021057
- 20888937009495
- 550031623
- 20888937009525
- 550031625
- Model code
- 44-0712
- 44-0707
- 44-0709
- 44-0715.
INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box.
- UDI-DI
- 20888937009433
- 550019722
- 60888937009448
- 550031617
- 550033781
- 550031621
- 20888937009457
- 550031615
- 550031616
- 550031620
- 550034760
- 20888937009464
- 550031611
- 550031614
- 550033779
- 550031619
- 20888937009471
- 550031618
- 550033780
- 550034763
- Model code
- 44-2707
- 44-2709
- 44-2710
- 44-2712
- 44-2715.
Details
- Company began the recall
- Sold in
Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.
- Event ID
- 99643
- Recall numbers
- Z-3139-2026 to Z-3140-2026
- Company
- CooperSurgical, Inc.Trumbull, Connecticut
- Hazard
- Device defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
