INCA Infant Nasal CPAP Recall
INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709…
Why was INCA Infant Nasal CPAP recalled?
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
1. Model Number: 44-2707. UDI-DI: (01)20888937009433. Lot Code: 550019722. 2. Model Number: 44-2709. UDI-DI: (01)60888937009448. Lot Codes: 550031617, 550033781, 550031621. 3. Model Number: 44-2710. UDI-DI: (01)20888937009457. Lot Codes: 550031615, 550031616, 550031620, 550034760. 4. Model Number: 44-2712. UDI-DI: (01)20888937009464. Lot Codes: 550031611, 550031614, 550033779, 550031619. 5. Model Number: 44-2715. UDI-DI: (01)20888937009471. Lot Codes: 550031618, 550033780, 550034763.
- Product
- INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709…
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 2,643 boxes (13,215 units)
- Distribution
- Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.
- Recall started
- August 11, 2026
- Report date
- September 30, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)