Recall Z-3140-2026— CooperSurgical, Inc.

Name: FDA recall Z-3140-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-11

Class I · Ongoing

Class I FDA medical device recall by CooperSurgical, Inc., initiated 2026-08-11. It names one FDA 510(k) clearance: K911780. 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..

Recalling firm: CooperSurgical, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2026-08-11
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K911780 — INFANT NASAL CANNULAE ASSEMBLY, MODIFIEDAckrad Laboratories·cleared 1991-06-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.