Z-3139-2026Class I

CooperSurgical, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm

Product type

Device

Status

Ongoing

Report date

2026-09-30

Distribution

Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.

Firm state

Product quantity

2,643 boxes (13,215 units)

Initiated by

Voluntary: Firm initiated

Reason for recall

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.

Product description

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.

Code / lot info

1. Model Number: 44-2707. UDI-DI: (01)20888937009433. Lot Code: 550019722. 2. Model Number: 44-2709. UDI-DI: (01)60888937009448. Lot Codes: 550031617, 550033781, 550031621. 3. Model Number: 44-2710. UDI-DI: (01)20888937009457. Lot Codes: 550031615, 550031616, 550031620, 550034760. 4. Model Number: 44-2712. UDI-DI: (01)20888937009464. Lot Codes: 550031611, 550031614, 550033779, 550031619. 5. Model Number: 44-2715. UDI-DI: (01)20888937009471. Lot Codes: 550031618, 550033780, 550034763.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →