INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recall
CooperSurgical, Inc. recalled INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set on September 30, 2026 because of 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. It was sold nationwide.
Why it was 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's recalled
INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Numbers: 44-2707, 44-2709, 44-2710, 44-2712, 44-2715.
Quantity: 2,643 boxes (13,215 units)
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- CooperSurgical, Inc., Trumbull, CT
- Date
- Severity
- Class I · most serious
the most serious: the product could cause serious health problems or death. - Where sold
- Nationwide
Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru. - Status
- Ongoing
- Recall number
- Z-3139-2026
- Source
- U.S. Food and Drug Administration
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