Recall Z-3140-2026 ยท BZD Ventilator, Non-Continuous (Respirator)
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.
| Date | Sep 18, 2026 (initiated Aug 11, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | CooperSurgical notified consignees on about 08/11/2026 via "URGENT Medical Device Recall" letter. Consignees were notified of the issue and potential hazard, and were instructed to identify affected units on hand, if any loose connection is recognized during the use of the CPAP, replace the tubing with another tubing or CPAP device, and remove all product of the subject lots from inventory and note the number of units to be returned on the attached Recall Response Form that is provided. Distributors were instructed to remove all product of the subject lots from inventory and note the number |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K911780 | INFANT NASAL CANNULAE ASSEMBLY, MODIFIED Ackrad Laboratories, Jun 24, 1991 |