Medical Device Recall: 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.
CooperSurgical, Inc. · August 11, 2026
Reason for Recall
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.
Distribution
Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.
States Affected
NATIONWIDE
Quantity Affected
149 boxes (745 units)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3140-2026
Status: ongoing
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