CooperSurgical, Inc. — 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 product recall notices and clearly labeled enforcement reference records.
Reference record — not a live warning · enforcement-reference · official-source
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.
- Provider
- FDA — device enforcement reference
- Source observed
- 8/11/2026, 12:00:00 AM UTC
- Source updated
- 9/18/2026, 12:00:00 AM UTC
- Location
- Trumbull, CT, US
- 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.
- notice
- Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
- 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.
- distribution
- Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.
- event number
- 99643
- manufacturer
- CooperSurgical, Inc.
- recall number
- Z-3140-2026
- source status
- Open, Classified
- freshness minutes
- 180
Source use policy · openFDA reference data; not a real-time public alert service
Update history (1 recent revisions)
- 10/8/2026, 2:10:44 AM UTC
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