FDA Device recall Z-3140-2026
INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set
- FDA Device
- Class I
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class I recall of INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set by Coopersurgical, citing 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 red….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3140-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-08-11 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Coopersurgical |
| Distribution | US |
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.
Identifiers
| code_info | 1. Model Number: 44-0712. UDI-DI: (01)60888937009516. Lot Code: 550031624. 2. Model Number: 44-0707. UDI-DI: (01)2088…1. Model Number: 44-0712. UDI-DI: (01)60888937009516. Lot Code: 550031624. 2. Model Number: 44-0707. UDI-DI: (01)20888937009488. Lot Code: 550021057. 3. Model Number: 44-0709. UDI-DI: (01)20888937009495. Lot Code: 550031623. 4. Model Number: 44-0715. UDI-DI: (01)20888937009525. Lot Code: 550031625. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
Other recalls by Coopersurgical
- INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set
FDA Device · Class I · 2026-09-30 · Coopersurgical - Endosee System Convenience Kit with IV Tube
FDA Device · Class II · 2025-07-30 · Coopersurgical - Endosee System Convenience Kit
FDA Device · Class II · 2025-07-30 · Coopersurgical - HSG Procedure Tray
FDA Device · Class II · 2025-07-30 · Coopersurgical - Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software Version: N/A Product Description: An electrically-pow…
FDA Device · Class II · 2024-12-25 · Coopersurgical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3140-2026%22
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