FDA · Class I · September 30, 2026

CooperSurgical recall: INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing… and 1 more product

CooperSurgical, Inc. is recalling INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing… and 1 more product – 2,643 boxes (13,215 units); 149 boxes (745 units). The U.S. Food and Drug Administration published the recall on September 30, 2026; it began on August 11, 2026. Distributed nationwide.

Most serious Class I is the most serious level: a reasonable probability that using or eating the product will cause serious health problems or death.

Illustration: An FDA laboratory that tests medical devices – not the recalled product. Photo: U.S. Food and Drug Administration, public domain.

Product	INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing… and 1 more product
Brand	CooperSurgical
Company	CooperSurgical, Inc.
Type	Medical devices
Classification	Class I
Recall date	August 11, 2026
Published by FDA	September 30, 2026
Quantity	2,643 boxes (13,215 units); 149 boxes (745 units)
Recall ID	99643

As listed by FDA

Recalled products (2)

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.
FDA recall number
Z-3139-2026
Codes, lots and dates
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.
Quantity
2,643 boxes (13,215 units)
Classification
Class I
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.
FDA recall number
Z-3140-2026
Codes, lots and dates
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.
Quantity
149 boxes (745 units)
Classification
Class I

Exactly as the agency lists them

Identifiers and details

FDA event ID: 99643
Initiated: Voluntary: Firm initiated
Status: Ongoing
Firm location: Trumbull, CT, United States

Why it was recalled

The reason the FDA lists: “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.”

Where it was sold

Nationwide. Distribution as the FDA records it: “Nationwide distribution to CT, FL, GA, IA, IL, IN, MD, MI, MS, NJ, NY, OH, PA, VA. International distribution to Brazil and Peru.”

What to do

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Official notice: FDA Enforcement Report record (event 99643, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

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FAQ

About this recall

Is CooperSurgical INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing… recalled?

Yes. CooperSurgical, Inc. recalled it on August 11, 2026; FDA published it September 30, 2026 (Class I). Only the lots, dates or models listed on this page are included.

Why was it recalled?

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.

What should I do if I have it?

Where was it sold?

Nationwide.

Recalls

More recalls

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.