- Recalling firm
- CooperSurgical, Inc.
- 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.
- Affected products (lot / model / serial)
- 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.
- Units affected
- 2,643 boxes (13,215 units)
- Distribution pattern
- Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.
- Firm location
- Trumbull, CT, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3139-2026
- Recall initiated
- August 11, 2026
- FDA classification date
- September 18, 2026
- FDA report date
- September 30, 2026
- FDA event ID
- 99643
- Last updated on HTM Vibe
- October 6, 2026
