CooperSurgical Recalls Neonatal Nasal CPAP Replacement Sets Due to Loose Tubing
CooperSurgical is recalling 149 boxes of INCA Neonatal Nasal CPAP replacement sets because the flexible tubing may disconnect from the nasal cannula, potentially reducing treatment effectiveness.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used for infant oxygenation where a defect could lead to decreased oxygenation, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
CooperSurgical, Inc. is recalling 149 boxes (745 units) of INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Sets. The affected product includes the Stay-Flex tubing component and is identified by specific model numbers and lot codes. The recall covers units distributed nationwide to 14 states and internationally to Brazil and Peru.
The recall was initiated because the flexible tubing may exhibit a loose connection with the nasal cannula during assembly or while in use. This defect may result in a loss of CPAP pressure, which can reduce the effectiveness of treatment and lead to decreased oxygenation until the connection is restored.
Healthcare facilities and consumers who possess these specific model numbers and lot codes should stop using the product and contact CooperSurgical, Inc. for instructions on return or replacement. The affected model numbers are 44-0712, 44-0707, 44-0709, and 44-0715.
The recalled product
- Product
- INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-0712, 44-0707, 44-0709, 44-0715.
- Manufacturer
- CooperSurgical, Inc.
Distribution
Related recalls
Same manufacturer · CooperSurgical, Inc.
See all →- HighCooperSurgical Recalls Infant Nasal CPAP Tubing Due to Loose Connection Risk
FDA (Devices) · 2026-09-30
- HighEndosee system convenience trays label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
- HighEndosee convenience kits label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
- HighHSG procedure trays label non-sterile iodine pouches as sterile
FDA (Devices) · 2025-07-30
- HighK-Systems G85 Mini Incubator May Exceed Desired Temperature
FDA (Devices) · 2024-12-25
Same hazard · loss of pressure
See all →- HighBoston Scientific Hurricane RX Dilation Balloon Recalled for Pressure Loss Defect
FDA (Devices) · 2021-12-08
- HighFord Recalls 2020 F-150 Trucks Due to Damaged Spare Tires
NHTSA · 2019-12-18
- SevereToyo Recalls Tires Due to Tread and Belt Separation Risk
NHTSA · 2014-11-04
- SevereFederal Couragia A/T Tires Recalled for Steel Belt Separation
NHTSA · 2014-04-18
- HighDePuy Spine Recalls Confidence Spinal Cement System 5cc Kits
FDA (Devices) · 2013-09-11