Reported Sep 30, 2026 · Ongoing · Updated Oct 6, 2026
INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box.…
CooperSurgical, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: CooperSurgical, Inc. · 95 Corporate Dr · Trumbull, CT · 06611-1350
Is this the product you have?
- INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box
- Model Numbers
44-071244-070744-070944-0715
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Barcodes Product as published 44-0712.60888937009516UDI-DI: (01)60888937009516. Lot Code: 550031624. 44-0707.20888937009488UDI-DI: (01)20888937009488. Lot Code: 550021057. 44-0709.20888937009495UDI-DI: (01)20888937009495. Lot Code: 550031623. 44-0715.20888937009525UDI-DI: (01)20888937009525. Lot Code: 550031625. - Amount recalled
- 149 boxes (745 units)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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