# Class I recall Z-3140-2026: CooperSurgical, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 76/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-3140-2026 |
| Recalling firm | CooperSurgical, Inc. |
| Classification | Class I |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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. |
| Reason | 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. |
| Quantity | 149 boxes (745 units) |
| Distribution | Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru. |
| Recall initiated | 2026-08-11 |
| Reported | 2026-09-30 |
| Firm location | Trumbull, CT, United States |

## Why this score
- Class I recall: the most serious category, typically requiring urgent corrective and preventive action (CAPA).
- Recall is still ongoing.
- Posted 36 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3140-2026%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.