INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP Lawsuit: What Owners Need To Know

Lawsuits have been filed in federal court against CooperSurgical, Inc. in the weeks after the company recalled certain lots of its INCA infant nasal CPAP sets. Families following the inca (infant nasal cannulae assy) neonatal nasal cpap lawsuit filings should know that the litigation is just beginning. Two individual product liability cases have been filed in two federal districts.

No court has ruled on the merits, and no consolidated proceeding exists. This article covers what was recalled, why it was recalled, what the court filings show so far, and what hospitals and families should do now.

What Was Recalled: INCA Neonatal Nasal CPAP Replacement Sets

The recalled product is the INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP Replacement Set, made by CooperSurgical, Inc. Each set includes a Stay-Flex tubing component, and each box holds five units. The FDA device recall record lists model numbers 44-0707, 44-0709, 44-0712, and 44-0715. It reports 149 units affected for this replacement set. Only specific lot codes within those models are part of the recall, so check the lot number on any product you have against the FDA’s published list.

The replacement set is part of a wider CooperSurgical action. According to the U.S. Food and Drug Administration, the same recall also covers INCA Infant Nasal CPAP Complete Sets (models 44-2707, 44-2709, 44-2710, 44-2712, and 44-2715), each with the same Stay-Flex tubing component. FDA records show the company started the action on August 11, 2026, and the agency posted it in September 2026. The FDA classified it as Class I, its most serious recall category. That category applies when use of a product may cause serious adverse health consequences.

Nasal CPAP (continuous positive airway pressure) is a common breathing support in neonatal intensive care units. A nasal cannula fitted to the infant’s nose delivers gentle, steady air pressure that helps keep the baby’s airways and lungs open. These devices are used mostly in hospitals, often for premature newborns or newborns with breathing problems.

Why the INCA CPAP Sets Were Recalled

The recall notice says affected units may have a loose connection between the flexible tubing and the nasal cannula, either during assembly or while in use. If no one catches the loose connection during assembly or placement, the FDA says the tubing may leak at the cannula connection or come off the cannula completely.

The clinical risk is a loss of CPAP pressure. The recall record says this could reduce the effectiveness of treatment. The FDA’s public notice adds that it could lead to decreased oxygenation of the patient until the connection is restored. For a fragile newborn who depends on steady airway pressure, even a short interruption can matter, which is why the recall received the FDA’s highest risk classification.

When the company first notified customers in August 2026, it said it had received no reports of serious injuries or deaths linked to the issue. That statement reflects what was known when the recall began. It is not a finding about any individual case.

Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP Lawsuit: What Has Been Filed

Federal court records on CourtListener, which draws from PACER, show two lawsuits filed against CooperSurgical, Inc. in October 2026:

Abraham v. CooperSurgical, Inc. was filed on October 29, 2026, in the U.S. District Court for the Middle District of Florida. The case is categorized under nature-of-suit code 365, Personal Injury – Product Liability. The docket is available at CourtListener.

L.B. v. CooperSurgical, Inc. was filed on October 23, 2026, in the U.S. District Court for the District of New Mexico. The case is categorized under nature-of-suit code 367, Personal Injury – Health Care/Pharmaceutical Personal Injury Product Liability. The plaintiff is identified by initials in the case caption. The docket is available at CourtListener.

That is two filings across two federal districts. Each is an individual lawsuit brought on behalf of a specific plaintiff. Neither is a group or representative case. Both were filed within about a month of the FDA’s public posting of the recall, but the litigation is at a very early stage. As of the dates above, the defendant may not yet have responded, and the court has made no findings.

What the Lawsuits Allege

The nature-of-suit codes show that both cases are personal injury product liability claims. The New Mexico case is specifically coded as a health care or pharmaceutical product liability claim. In cases of this type tied to a medical device recall, plaintiffs usually claim that a product was defectively designed or manufactured, or that the manufacturer did not give adequate warnings, and that the defect caused physical harm.

For the INCA recall, the defect at issue would be the one described in the recall: a tubing-to-cannula connection that can loosen, leak, or come apart, which may cause a loss of CPAP pressure and lower oxygen delivery to an infant. Readers should be careful on one point. CourtListener docket summaries show the parties, court, filing date, and case category.

They do not by themselves show the specific product, injuries, or legal theories in each complaint. CooperSurgical makes a range of medical products, and the details of each plaintiff’s claims will come from the complaints and later court filings. Specific claims should not be assumed until those documents are reviewed.

No Consolidated Proceeding Exists Yet

When many similar lawsuits are filed in different federal courts, the Judicial Panel on Multidistrict Litigation can transfer them to a single judge for coordinated pretrial proceedings. That has not happened here. No multidistrict litigation or other consolidated proceeding has been created for claims involving the INCA nasal CPAP sets. The two cases are proceeding separately in Florida and New Mexico. Whether more cases will be filed, or whether coordination will ever be requested, is not known.

Because the litigation is so new, there are no settlements, verdicts, or court-approved resolutions. Any claim about payout amounts or guaranteed outcomes at this stage is speculation.

What to Do Now If You Have or Used an Affected INCA CPAP Set

Hospitals, NICUs, and distributors: Follow the recall instructions. The FDA says users should identify affected lots, stop using and distributing them, take them out of inventory, and return them to CooperSurgical. If staff notice a loose connection while the device is in use, the FDA notice says to replace the tubing with other tubing or switch to another CPAP device. Facilities that passed the product on to others should notify those customers. CooperSurgical’s recall support team can be reached at [email protected] or 203-895-2789.

Preserve evidence: If an affected set is involved in a suspected malfunction, keep the device, its packaging, and any labels showing the model and lot number instead of throwing them away. Keep purchase records, invoices, recall notices, and internal incident reports. Physical evidence and documents are often central to product liability claims, and they can be lost quickly in a hospital setting.

Families: Most parents never handle these sets directly, because hospital staff set them up and manage them. If your infant received nasal CPAP and you are worried about a possible equipment problem, you can ask the treating hospital for your child’s medical records, including respiratory therapy notes and any record of the equipment used. Talk with your child’s physicians about any health concerns.

Report problems: Clinicians, facilities, and families can report adverse events or device malfunctions to the FDA through the MedWatch Safety Information and Adverse Event Reporting Program. These reports help the agency track how widespread a problem is.

Where to Find Official Information

Use the FDA’s recall records as the main source for affected models, lot numbers, and the current recall status. The FDA recall database is available at accessdata.fda.gov, and the agency has posted a public notice on its Medical Device Recalls page. Court dockets for the two lawsuits can be followed on CourtListener at the links above. Filings there may change as the cases move forward.

The Bottom Line

CooperSurgical’s INCA Neonatal Nasal CPAP Replacement Sets were recalled because the tubing can loosen from the nasal cannula, which may cause a loss of CPAP pressure and lower oxygen delivery to newborns. Two individual product liability lawsuits have since been filed against CooperSurgical, one in the Middle District of Florida and one in the District of New Mexico. The litigation is beginning, no consolidated proceeding exists, and no court has decided any claim.

Anyone who has affected product should follow the recall instructions, keep the device and related records, and use official FDA and court sources for updates. This article is general legal information, not legal advice. People with questions about their own situation should talk with a licensed attorney.

Were You Injured by a Recalled Product?

A recall by itself is a safety action, not a legal claim. However, if a recalled product caused a real injury, you may be eligible to pursue compensation. A licensed attorney can review your situation at no upfront cost — most work on contingency, meaning you pay nothing unless you recover.

Official Sources & Resources

Verify every recall against the issuing agency before acting:

• U.S. Food and Drug Administration: official recall database — the record of truth for this notice
• CPSC: cpsc.gov — household goods, toys, furniture, appliances
• FDA: fda.gov — food, drugs, and medical devices
• NHTSA: nhtsa.gov — vehicles, tires, and child car seats
• USDA FSIS: fsis.usda.gov — meat, poultry, and egg products

Content last reviewed November 2026. This is general educational information, not legal advice. If you notice outdated information, please contact us.

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Attorney Advertising. The information on this page is provided for general informational purposes only and does not constitute legal advice. A product recall is a safety action by a manufacturer or regulator and does not by itself establish liability or create a legal claim. No attorney-client relationship is created by accessing or using this content. Every case is unique. If you believe you were harmed by a recalled product, consult a licensed attorney in your jurisdiction.