Z-3140-2026Class I

INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units...

Name: Z-3140-2026 INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing component. 5 units...
Creator: CooperSurgical, Inc.
Published: 2026-08-11
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2026-08-11 / Open, Classified

FDA source

Recall record

Recall number: Z-3140-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-08-11
Posted: 2026-09-18
Recalling firm: CooperSurgical, Inc.
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.
Product code: BZD Ventilator, Non-Continuous (Respirator)
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.
FDA 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 of units to be returned on the attached Distributor Only Acknowledgement Form. Additionally, they were instructed to communicate the recall notification to all customers that they distributed these devices to.
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3140-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3139-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18
Z-3140-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-18

Product code BZD

K911780Class IIInfant Nasal Cannulae Assembly, ModifiedAckrad Laboratories / cleared 1991-06-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-23. View this recall on fda.gov (opens on fda.gov)