FDA-Device2026-09-30Class IPROCESSING DEFECT

CooperSurgical INCA neonatal nasal CPAP tubing recalled for loose connection risk

OTHERNationwide distributionMedical devicesBaby & kids

What this means

CooperSurgical's INCA neonatal nasal CPAP replacement tubing sets may develop a loose connection between the flexible tubing and nasal cannula during assembly or use. A loose connection can cause loss of CPAP pressure, potentially reducing treatment effectiveness and oxygen delivery to the infant until the connection is restored.

  • Check your INCA CPAP tubing for model numbers 44-0712, 44-0707, 44-0709, or 44-0715 and the lot codes listed in the recall notice.
  • Inspect the connection between the tubing and nasal cannula for tightness before each use.
  • Contact CooperSurgical or your equipment supplier immediately if you have affected units or have questions about replacement.
Get recalls like this in a free plain-English brief every Sunday.Get alerts ↓
The agency's original wording
Hazard

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.

Intended for
Infants (under 12 months)
Illnesses reported
None reported
Sold states
Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.
Affected count
149 boxes (745 units)
Manufactured in
95 Corporate Dr, Trumbull, CT, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3140-2026

More CooperSurgical recalls

Want us to check the next one for you?

We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Free · One email a week · Unsubscribe anytime
By signing up you agree to our Terms and Privacy Policy.