Recall Summary
| Recall number | Z-3140-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-09-30 |
| Company | CooperSurgical, Inc. |
| Units affected | 149 |
| Severity | Class I |
Remedy: Follow the instructions in the official notice linked below. The agency record for this recall did not contain remedy text we could verify against this product, so we have not reproduced it here.
Read the official U.S. Food and Drug Administration recall notice
coopersurgical inca recall news affects one of the most fragile groups of patients in any hospital. On September 30, 2026, the U.S. Food and Drug Administration posted a Class I recall for CooperSurgical, Inc. It covers INCA Neonatal Nasal CPAP Replacement Sets, which help newborns breathe. The problem is a possible loose connection between the tubing and the nasal cannula. As a result, CPAP pressure could drop during treatment. Class I is the FDA’s most serious recall category.
What the Coopersurgical Inca Recall Covers
The CooperSurgical INCA recall covers the INCA Infant Nasal Cannulae Assy. INCA is the product’s short name. The recalled item is a Neonatal Nasal CPAP Replacement Set. It includes a Stay-Flex tubing component. Each box contains 5 units.
The FDA record lists four model numbers. They are 44-0712, 44-0707, 44-0709, and 44-0715. A box showing one of these numbers falls within the recall. The agency lists 149 units in total. That is a small number compared with many device recalls. However, the small scope does not make it less serious. The FDA still placed it in Class I.
The agency data summarized here does not list lot codes or sale dates. It also does not name distribution states. For that detail, check the official FDA notice linked on this page. Typically, products like these are sold to hospitals and neonatal intensive care units. In most cases, parents never buy them directly. Instead, clinicians choose and assemble the equipment at the bedside.
This matters for families. Your baby may have used this equipment without you knowing the brand. For example, a NICU may stock several cannula brands at the same time. As a result, the care team is often the best source of information. You can ask them directly whether the recalled sets were used.
The Hazard and Reported Injuries
The core issue in the CooperSurgical INCA recall is a connection problem. According to the FDA, the flexible tubing may not stay firmly attached to the nasal cannula. The loose connection can happen during assembly. It can also happen while the device is in use. When that link loosens, CPAP pressure can be lost.
Nasal CPAP keeps gentle, steady pressure in a baby’s airway. That pressure helps hold small airways open. Premature infants often need this support. If pressure drops, treatment may become less effective. The FDA record states this could lead to decreased oxygenation until the connection is restored.
Decreased oxygenation means less oxygen reaches the blood. For a fragile newborn, even short drops can be a concern. That is one reason the FDA treats this issue so seriously. A Class I recall involves a reasonable chance that use could cause serious health problems or death.
The agency record does not state whether any injuries have been reported. This guide does not claim either way. If you have questions about a specific child, talk with the treating medical team. They can review care records and monitoring data.
| Recall Number | Z-3140-2026 |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Date | September 30, 2026 |
| Company | CooperSurgical, Inc. |
| Product | INCA Neonatal Nasal CPAP Replacement Set (Models 44-0712, 44-0707, 44-0709, 44-0715) |
| Units Affected | 149 units |
| Severity | Class I |
What To Do If You Own This Product
Most owners of this product are hospitals, clinics, and NICU teams. If your facility stocks sets covered by the CooperSurgical INCA recall, check inventory now. Look for model numbers 44-0712, 44-0707, 44-0709, and 44-0715. Set aside any matching boxes. Then follow your facility’s recall procedures.
Do not rely on secondhand summaries for the fix. The remedy text in the public agency record did not match this product. For that reason, we have not listed a remedy here. Instead, follow the instructions in the official FDA recall notice. You can also contact CooperSurgical, Inc. directly for guidance.
Parents and caregivers should never try to adjust a baby’s breathing equipment. However, you can always ask questions. For example, ask the nurse whether your baby’s CPAP set is part of the CooperSurgical INCA recall. Ask how the team checks connections during care. In most cases, staff will gladly explain their process.
If you believe a device problem affected a patient, you can report it. The FDA runs a reporting program called MedWatch. Health professionals and families can both file reports. These reports help the agency track device problems. Keep copies of any records, photos, or notices you receive.
Does a Coopersurgical Inca Recall Mean You Can Sue?
A recall is not a lawsuit. It is a safety action. The CooperSurgical INCA recall warns the public that a product may pose a risk. It does not mean anyone has filed a claim. It also does not mean anyone is owed money.
We have not verified any lawsuit tied to this recall. A recall alone is not a legal claim. Typically, a product liability case needs more than a recall notice. It usually requires a real injury. It also requires proof that the product caused that injury.
📨 Get Free Mass Tort Guides Alerts
Free · No spam · Unsubscribe anytime
For example, a family would need medical records showing harm. They would also need evidence linking that harm to the device. That link is called causation. Proving it can be complex in neonatal care. Premature babies face many health risks unrelated to equipment.
If you think your child was harmed, consider speaking with a licensed attorney. Many product liability lawyers offer free consultations. They can review your situation and explain your options. You may be eligible to pursue a claim, depending on the facts. However, no one can guarantee an outcome. Filing deadlines also vary by state.
How Recalls Connect to Mass Tort Cases
Recalls sometimes become important evidence in later litigation. A recall notice can show when a company learned of a problem. It can also show how the company described the risk. As a result, attorneys often review recall records closely. However, a recall does not prove fault on its own.
The Philips CPAP case is one well-known example. In June 2021, Philips Respironics recalled millions of breathing devices. The concern was sound-reducing foam that could break down. Many lawsuits followed. Federal courts later consolidated those cases in Pennsylvania.
Takata airbags offer another example. Defective inflators could rupture and send metal fragments into vehicles. The recalls became the largest in U.S. auto history. Litigation continued for years. In both cases, the recall came first. Lawsuits grew later, based on injuries and evidence.
It is too early to say whether the CooperSurgical INCA recall will follow a similar path. Many recalls never lead to mass tort cases. This one involves 149 units, which is a small scope. We will update this guide if verified legal developments occur.
Frequently Asked Questions
What products are part of the CooperSurgical INCA recall?
The recall covers INCA Neonatal Nasal CPAP Replacement Sets with Stay-Flex tubing. Model numbers are 44-0712, 44-0707, 44-0709, and 44-0715. Each box holds 5 units, and 149 units are affected.
Why is the CooperSurgical INCA recall classified as Class I?
The tubing may loosen from the nasal cannula during assembly or use. This can cause loss of CPAP pressure and decreased oxygenation. Class I is the FDA’s most serious recall category.
Can I file a lawsuit over the CooperSurgical INCA recall?
A recall by itself is not a lawsuit or a claim. If a child was injured and the device may have caused it, you may be eligible to pursue a claim. A licensed attorney can review the facts.
What should a hospital do with recalled INCA sets?
Check inventory for the listed model numbers and set aside any matches. Then follow the instructions in the official FDA notice. Contact CooperSurgical, Inc. with any questions.
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 October 2026. This is general educational information, not legal advice. If you notice outdated information, please contact us.
Related Guides
- All Product Recalls
- All Active MDL Cases
- Mass Tort Explainers
- Mass Tort Tips
- Tort Reform by State — 50-State Comparison
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.