FDA Early Alert on CooperSurgical INCA Neonatal/Infant Nasal CPAP Sets: Affected Lots, Required Actions and Regulatory Implications

FDA Early Alert: CooperSurgical INCA Neonatal and Infant Nasal CPAP Sets

On August 12, 2025, the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) issued an Early Alert concerning a ventilator issue involving CooperSurgical. CooperSurgical has sent a letter to affected customers recommending that specific lots of INCA neonatal/infant nasal CPAP complete sets and replacement sets be removed from the locations where they are used or sold. The reason is that the connection between the flexible tubing and the nasal prongs may loosen, resulting in leakage or disconnection, which can in turn cause loss of CPAP pressure and decreased patient oxygenation. FDA is evaluating this potentially high-risk device issue. Affected companies should verify lot numbers, stop use, and return the products, while monitoring for further updates.

This article is compiled and translated from public information published by FDA CDRH News & Updates. Source: https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-ventilator-issue-coopersurgical. Specific requirements are subject to the latest official release by the regulatory authority.

Key Takeaways

• FDA CDRH has issued an Early Alert on a potentially high-risk device issue involving CooperSurgical INCA nasal CPAP products.
• CooperSurgical has notified affected customers and recommended removal of specific lots from use or sale locations.
• The suspected failure mode is loosening of the connection between the flexible tubing and the nasal prongs, leading to leakage or disconnection, loss of CPAP pressure and reduced patient oxygenation.
• Affected customers should identify affected lots, stop use and distribution, quarantine and return the products to CooperSurgical, and notify relevant staff.
• FDA is reviewing the information and will update its page as significant new information becomes available.

Source and Applicability

• Source organization: FDA CDRH News & Updates
• Alert date: August 12, 2025
• Manufacturer notice to affected customers: August 11
• Source link: https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/early-alert-ventilator-issue-coopersurgical

This article is compiled and translated from public information released by FDA CDRH News & Updates. Specific requirements are subject to the latest official publication by the regulatory authority.

Full Translation of the FDA Early Alert

The FDA's Center for Devices and Radiological Health (CDRH) is issuing this Early Alert to inform the public about a potentially high-risk device issue. FDA will keep the public informed as significant new information becomes available and will update this page accordingly.

Affected Products

FDA is aware that CooperSurgical has sent a letter to affected customers recommending the removal of certain ventilators from use or sale locations.

Affected devices include:

• INCA Infant Nasal Continuous Positive Airway Pressure (CPAP) Complete Set, Part Number 44-2707, Lot 550019722, Product UDI: (01) 20888937009433
• INCA Infant Nasal CPAP Complete Set, Part Number 44-2709, Lots 550031617, 550033781, 550031621, Product UDI: (01) 60888937009448
• INCA Infant Nasal CPAP Complete Set, Part Number 44-2710, Lots 550031615, 550031616, 550031620, 550034760, Product UDI: (01) 20888937009457
• INCA Infant Nasal CPAP Complete Set, Part Number 44-2712, Lots 550031611, 550031614, 550033779, 550031619, Product UDI: (01) 20888937009464
• INCA Infant Nasal CPAP Complete Set, Part Number 44-2715, Lots 550031618, 550033780, 550034763, Product UDI: (01) 20888937009471
• INCA Neonatal Nasal CPAP Replacement Set, Part Number 44-0712, Lot 550031624, Product UDI: (01) 60888937009516
• INCA Neonatal Nasal CPAP Replacement Set, Part Number 44-0707, Lot 550021057, Product UDI: (01) 20888937009488
• INCA Neonatal Nasal CPAP Replacement Set, Part Number 44-0709, Lot 550031623, Product UDI: (01) 20888937009495
• INCA Neonatal Nasal CPAP Replacement Set, Part Number 44-0715, Lot 550031625, Product UDI: (01) 20888937009525

Actions to Take

Do not use affected products. Identify affected products, stop use and distribution, and return them to CooperSurgical.

On August 11, CooperSurgical sent a letter to all affected customers recommending the following actions:

• If a loose connection is observed during CPAP use, replace the tubing with other tubing or a different CPAP device.
• Stop further use or distribution and quarantine the affected product.
• Notify the relevant personnel within your facility who use these devices.
• If the product has been transferred to another facility, contact that facility and provide the company notice.

Please monitor this page for updates. FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

Reason for the Alert

CooperSurgical states that, for certain lots of INCA neonatal nasal CPAP complete sets and replacement sets, the connection between the flexible tubing and the nasal prongs may loosen during assembly or use. If a loose connection is not identified during assembly and/or placement, the tubing may leak at the nasal prong connection or disconnect from the nasal prongs. This can result in loss of CPAP pressure, reduced treatment effectiveness, and decreased patient oxygenation until the connection is restored.

As of August 11, CooperSurgical had not reported any serious injuries or deaths related to this issue.

Device Intended Use

The INCA Infant Nasal CPAP device is a medical device designed to provide continuous positive airway pressure (CPAP) to neonatal and infant patients who require respiratory support. The system consists of a transparent, soft nasal prong and two malleable Stay-Flex tubes that hold their position to reduce patient movement and nasal trauma. The set includes a built-in tubing adapter, an in-line pressure adapter, a knitted cap with a retention strap, and a chin strap used to control leak and secure the circuit.

Contact Information

U.S. customers who experience adverse events or quality problems, or who have questions about this issue, may contact the CooperSurgical recall support team at fieldaction@coopersurgical.com or 203-895-2789.

Unique Device Identification (UDI)

Unique Device Identification (UDI) helps identify a single medical device from distribution through use in the United States. UDI enables more accurate reporting, review and analysis of adverse event reports, allowing faster device identification and, potentially, faster resolution of problems.

How to Report a Problem

Healthcare professionals and consumers can report adverse events or quality problems experienced with the use of these devices through MedWatch, the FDA Safety Information and Adverse Event Reporting Program.

Aimeili Regulatory Interpretation and Business Impact

What This Alert Means for Medical Device Companies

Information of this type, published in FDA CDRH News & Updates, should first be incorporated into a company's regulatory intelligence and post-market surveillance processes rather than read as ordinary news. Companies need to determine whether the update is a guidance document, a recall or safety communication, a product approval, a digital health item, a quality system matter, or post-market regulatory information, and then confirm whether it affects existing registration projects or products under development.

Where the content concerns a specific product, test performance, risk warning or regulatory action, companies should further assess whether it affects product classification, the 510(k), De Novo or PMA pathway, technical documentation, labeling and instructions for use, quality system records, or post-market reporting obligations. For companies pursuing U.S. market registration, the source link, publication date, scope of application and internal assessment conclusions should be recorded in the project file.

Which Documents Should Companies Review

Recommended areas of review include the basis for product classification, applicable regulatory provisions, predicate device or substantial equivalence determinations, performance testing, software and cybersecurity documentation, risk management, clinical evidence, labeling and instructions for use, and quality system readiness.

Common Risks

Common risks include misjudging the FDA pathway, overlooking changes in guidance documents, insufficiently designed performance testing, overly broad labeling claims, unclear post-market reporting obligations, and applying documentation prepared for other markets directly to U.S. registration.

Aimeili View

This FDA Early Alert on CooperSurgical INCA nasal CPAP is not a final recall order with definitive conclusions; it is a rapid risk communication issued by CDRH after receiving information about a potentially high-risk device issue. It sends an important signal to the medical device industry: FDA applies a high safety threshold to neonatal and infant respiratory support devices, and any connection reliability issue that could lead to pressure loss, leakage or circuit disconnection will be subject to close attention. Manufacturers, whether acting as original equipment manufacturers (OEMs), own-brand exporters or contract manufacturers, should treat early alerts of this kind as a trigger to review their own product design, verification records and post-market data.

First line: registration pathway and product classification. Nasal CPAP and respiratory support devices in the United States are generally regulated as Class II devices, and most require a 510(k) or an equivalent premarket pathway with a demonstration of substantial equivalence. Companies should not only check whether their own product is already cleared for marketing, but also monitor whether FDA expectations for substantial equivalence determinations, performance standards and clinical evidence may rise when comparable marketed products are questioned on safety grounds.

Second line: technical documentation and performance verification. Companies should review test data on connection force at the tubing-to-nasal-prong interface, seal integrity, leak rate, and stability under patient movement and pulling forces, and confirm whether the original verification protocol covered real-world use scenarios such as assembly misuse, incomplete insertion and repeated disassembly and reassembly. Where a product uses a malleable Stay-Flex style tube or a snap-fit connection design, additional testing simulating aging, kinking, tension and fixation failure in a clinical environment should be added.

Third line: labeling and instructions for use. The instructions for use should clearly instruct healthcare professionals to confirm that the connection is properly seated during setup and to monitor pressure, leakage and oxygenation during use, and to immediately replace the tubing or device if loosening is observed. From FDA's standpoint, labeling that omits these warnings and operating steps may be considered to provide insufficient information for the intended use and safe use of the device.

Fourth line: quality system and post-market surveillance. In accordance with ISO 13485 and FDA 21 CFR Part 820, companies should initiate a CAPA root cause assessment covering batch records, distribution records, complaints and MDR reports, and establish traceability from the UDI-DI through to the point of patient use. At the same time, they should evaluate whether other products with similar designs require preventive corrective action.

Immediate Self-Assessment for Companies Exporting to or Seeking FDA Registration in the United States

Chinese manufacturers exporting to the United States or planning to apply for FDA registration are advised to conduct an immediate self-assessment in three areas. First, check whether the company's U.S. product portfolio includes nasal CPAP devices, nasal prong and tubing components, connectors or respiratory support circuits that are identical or similar to INCA. Second, verify that UDI labeling and GUDID submission information are accurate and complete, so that lot numbers and product identifiers can be quickly recognized by FDA and healthcare facilities. Third, if there is a contract manufacturing or supply relationship with CooperSurgical, or if a distributor has received a related notice, cooperate immediately by suspending sales, quarantining inventory and communicating follow-up corrective actions to FDA. Even if the affected lots are unrelated to a Chinese company, the risk assessment records for similar products should be proactively updated.

Possible Escalation

FDA has stated that it is reviewing the information and will update the page, which means the matter may still escalate from an Early Alert to a formal recall, a safety communication, or an exchange of information with foreign regulators. Companies should not wait for a final determination before acting; instead, they should use the window of time to complete product gap comparisons, compile historical quality data and prepare corrective action plans. For products that already hold a 510(k) clearance or premarket approval, the alert should be included as an input to annual reviews and management reviews, with an assessment of whether risk management documentation, clinical evaluation or labeling warnings need to be updated. Overall, in the international medical device registration chain, post-market safety signals and official early alerts have become part of regulatory strategy, and companies must treat them with the same priority as registration submissions.

FAQ

Does an update to an FDA public page necessarily represent a regulatory change? No. Not every update represents a regulatory change. Companies need to distinguish between news items, guidance documents, database pages, recall information and formal regulatory documents, and important content should be verified against the original FDA source and the applicable regulations. Updates should be classified before any impact assessment is performed.

What should companies do after seeing an FDA update? First determine whether it affects product classification, the registration pathway, technical documentation or post-market obligations, and then decide whether the project plan needs to be updated. Documenting the reasoning and conclusions in the project file supports consistent decisions across regulatory, quality and commercial teams.

Editorial Review and Scope of Application

Content prepared by: Aimeili Regulatory Editorial Team. Professional review: Aimeili Medical Device International Registration Project Team. Source principle: priority is given to official regulatory authorities, international organizations, standards organizations and publicly available regulatory materials; industry media and project experience are used only as supporting input. Scope of application: this article is intended for preliminary understanding, documentation preparation and project planning, and does not replace the formal requirements of the target country regulator, testing conclusions or legal advice.