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 details were posted by the U.S. Food and Drug Administration on September 30, 2026. The action covers certain INCA Neonatal Nasal CPAP Replacement Sets made by CooperSurgical, Inc. These sets help deliver breathing support to newborns. The FDA classified the recall as Class I. That is the agency’s most serious category. The concern is a loose connection in the tubing. If it fails, CPAP pressure may drop and an infant may receive less oxygen.
This guide explains the coopersurgical inca recall in plain terms. It covers which products are affected and what can go wrong. It also lists practical next steps for hospitals, clinicians, and families. Finally, it explains how recalls relate to legal claims. The facts here come from the FDA record. Where that record is silent, we say so.
What the Coopersurgical Inca Recall Covers
The coopersurgical inca recall applies to the INCA Neonatal Nasal CPAP Replacement Set. INCA stands for Infant Nasal Cannulae Assembly. The affected part is the Stay-Flex tubing component. Each box contains 5 units. The FDA record lists four model numbers: 44-0712, 44-0707, 44-0709, and 44-0715.
According to the agency, 149 units are covered. That is a small number compared with many device recalls. However, recall size does not reflect risk level. A Class I label means the FDA sees a serious hazard. In most cases, Class I recalls involve products that could cause serious health problems or death.
Nasal CPAP stands for continuous positive airway pressure. It typically supports premature or ill newborns who need help breathing. The nasal cannula sits at the infant’s nose. Flexible tubing links the cannula to the CPAP system. The replacement set lets care teams swap out these parts as needed.
The FDA data we reviewed does not list specific lot codes. It also does not state exact sale dates or distribution areas. For example, it does not say which facilities received the sets. Check the official notice for full product details. Your supplier or CooperSurgical can also confirm whether your stock is affected.
The Hazard and Reported Injuries
The FDA describes a potential loose connection. The problem sits between the flexible tubing and the nasal cannula. It may appear during assembly. It may also appear while the device is in use. As a result, the device could lose CPAP pressure.
Loss of pressure matters because CPAP helps keep small airways open. When pressure drops, treatment may become less effective. According to the FDA, this could lead to decreased oxygenation. That risk continues until the connection is restored. For a fragile newborn, even a short drop in oxygen is a concern.
The agency record does not state whether any injuries have been reported. We do not claim that injuries occurred. We also do not claim that none occurred. Typically, the FDA updates its records if new information emerges. Check the official notice for the latest status of the coopersurgical inca recall.
The key facts from the FDA record appear below.
| Recall Number | Z-3140-2026 |
|---|---|
| Issuing Agency | U.S. Food and Drug Administration |
| Date | September 30, 2026 |
| Company | CooperSurgical, Inc. |
| Units Affected | 149 units |
| Severity | Class I |
Class I is the highest of three FDA recall classes. Class II covers products that may cause temporary or reversible health problems. Class III covers products unlikely to cause harm. The Class I label here signals that the FDA views this hazard as serious.
What To Do If You Own This Product
In most cases, neonatal CPAP sets are used under clinical supervision. Hospitals and neonatal units are the most likely holders of this product. However, clinics and medical suppliers may also have affected stock. If you manage medical supplies, check your inventory now. Compare your stock against the four listed model numbers.
Look for model numbers 44-0712, 44-0707, 44-0709, or 44-0715. Check box labels and product labeling for these numbers. If you find a match, set the product aside. Do not use it until you have reviewed the official instructions. Clinicians should follow facility protocols for any device in active use.
The agency record for this action contains remedy text that does not match the product. For that reason, we have withheld it. We do not state what the remedy is. Instead, follow the instructions in the official FDA notice for the coopersurgical inca recall. You can view it here: FDA recall enterprise system.
You can also contact CooperSurgical, Inc. directly. Ask whether your units are affected and what steps to take. If you are a parent, talk with your baby’s care team. They can explain what equipment was used. Healthcare staff can report device problems to the FDA through its MedWatch program.
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Does a Coopersurgical Inca Recall Mean You Can Sue?
A recall is not a lawsuit. It is a safety action taken by a company, often with FDA oversight. The coopersurgical inca recall aims to address a product with a known risk. It does not, by itself, create a legal claim. It also does not mean anyone was harmed.
A legal claim typically needs more than a recall. In most cases, a person must show a real injury. They must also show that the product likely caused that injury. Medical records and expert review often play a key role. For example, a lawyer may examine treatment logs and device records.
We have not verified any lawsuit tied to this recall as of October 7, 2026. That could change over time. If you believe your child was harmed, speak with a licensed attorney. Many product liability lawyers offer free consultations. They can review your facts and explain your options.
Results are never guaranteed. Every case depends on its own facts and the law in your state. You may be eligible to pursue a claim if injury and causation can be shown. However, filing deadlines called statutes of limitations apply. As a result, it is wise to ask questions early.
How Recalls Connect to Mass Tort Cases
Recalls sometimes become evidence in later litigation. A recall notice can show that a company identified a defect. Internal records tied to a recall may also surface during lawsuits. For example, Philips Respironics recalled millions of CPAP and BiPAP machines in 2021. Sound-dampening foam in those devices could break down. Many lawsuits followed, and Philips later agreed to major settlements.
The Takata airbag recall is another example. Defective inflators could rupture and spray metal fragments. It became one of the largest auto recalls in U.S. history. Litigation and settlements followed over several years. However, those cases involved documented injuries and very wide distribution.
Not every recall leads to a mass tort. Many recalls end without any litigation at all. The coopersurgical inca recall covers 149 units. The agency record does not state whether injuries occurred. Typically, mass torts form only when many people report similar harm. We will update this page if verified developments occur.
Frequently Asked Questions
What products are part of the coopersurgical inca recall?
The recall covers INCA Neonatal Nasal CPAP Replacement Sets with the Stay-Flex tubing component. Model numbers are 44-0712, 44-0707, 44-0709, and 44-0715. The FDA lists 149 units in scope.
Why is the coopersurgical inca recall rated Class I?
The flexible tubing may loosen from the nasal cannula. That could cause a loss of CPAP pressure and decreased oxygenation. Class I is the FDA’s most serious recall category.
Is there a lawsuit over the coopersurgical inca recall?
We have not verified any lawsuit tied to this recall. A recall alone is not a legal claim. If you believe a child was harmed, consult a licensed attorney about your options.
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.
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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.