Ventilator Recalled for Cybersecurity Risk

A recent cybersecurity risk recall of a ventilator serves as a real-life demonstration of the security risks that persist. The Food & Drug Administration (FDA) characterized this as a Class 1 recall. This designation means the issues could threaten patient safety. The manufacturer pulled the device as a precaution, as there are no reports of injuries or deaths.

The company first identified weaknesses in November of 2024 and completely pulled the device. It will no longer produce, distribute, or service these machines.

Ventilators are a critical component in keeping patients alive. A vulnerability in these devices has the potential to put patients at risk. While the hacking of medical devices in an attempt to hurt those using them has been rare, it’s still a legitimate threat.

So, why did the situation occur? Was the medical device secure by design?

Key Takeaways

• Unencrypted data and exposed ports led to a Class I recall.
• Basic secure by design principles were not effectively applied.
• Lack of integrated security created patient safety risks.
• Recall underscores the importance of premarket security measures.
• Manufacturers must prioritize cybersecurity from device conception.
• Postmarket monitoring and updates matter for device safety.

Table of Contents

• Key Takeaways
• What Is Secure by Design?
• The Advantages of Using Secure by Design in Medical Devices
• Medical Device Cybersecurity Compromise: What Were the Ventilator Weaknesses?
• What Can Medical Device Manufacturers Learn from this Recall?

Why this matters

Recalls like the recent ventilator event underscore the severe patient safety implications of inadequate cybersecurity in medical devices. The FDA's 'Cybersecurity in Medical Devices' Final Guidance, dated February 3, 2026, explicitly mandates that manufacturers integrate security early in the product lifecycle. Failure to adhere to secure by design principles, as evidenced by the ventilator recall, can result in devices with exploitable vulnerabilities such as unencrypted data or exposed access points. These weaknesses not only risk compromises to device functionality and patient data but can also lead to costly and reputation-damaging Class I recalls.

Manufacturers must implement security measures aligned with standards like AAMI SW96, IEC 81001-5-1, and ISO 14971 throughout development and postmarket phases. Ignoring these requirements is no longer an option; the FDA’s stringent premarket review now prioritizes a documented cybersecurity strategy from conception through postmarket monitoring. Proactive security, rather than reactive remediation, is essential to protect patients, maintain regulatory compliance, and ensure market access.

What Is Secure by Design?

Secure by design prioritizes security from the beginning of the device’s development life cycle. It’s a proactive framework, intending to mitigate security issues early. The result is typically a more robust and reliable product.

There are several key principles in secure by design, including:

• There is an emphasis on secure coding, with actionable outcomes such as the development of a software bill of materials (SBOM). It’s a requirement of the FDA per their 2023 guidance.
• Security is a core component, not a separate initiative.
• Initial development involves a risk-based method to identify and address risks.
• There’s consideration for security throughout the product’s life cycle, from conception to testing to in-use.

The Advantages of Using Secure by Design in Medical Devices

Medical device cybersecurity is constantly evolving as new threats emerge. It’s in flux right now for many reasons, including the cuts to the FDA and the Cybersecurity and Infrastructure Security Agency (CISA).

This volatile environment means that secure by design is more essential than ever. When manufacturers use this strategy, benefits include:

• Reduction in exploitable weaknesses: This can improve further with regular vulnerability scanning, a patching update workflow, and penetration testing.
• Enhanced reliability and resilience: Secure design principles deliver a system more able to handle cyberattacks. Medical devices must be reliable. Otherwise, providers and patients lose trust.
• Cost savings: Manufacturers following a secure-by-design approach can avoid expensive remediation efforts.
• Regulatory compliance: The FDA regulates these devices, and there are multiple regulations to adhere to. Secure by design helps ensure you are in compliance.

Medical Device Cybersecurity Compromise: What Were the Ventilator Weaknesses?

Secure by design may have been a goal of this manufacturer, but the findings of the risk imply it wasn’t effective.

The vulnerabilities detected included:

See also: NeuroTech Cybersecurity Risks: Neurostimulators, EEG, & BCI, The Overlooked Threat in MedTech Innovation, and Mastering Cybersecurity in MedTech.

• No encryption of passwords or other sensitive information, making it easy for hackers to access
• Physical port exposure, which would allow a hacker to plug a piece of hardware into the ventilator
• Minimal authentication for those testing and calibrating the device

These are glaring cybersecurity risks. However, all these things - encryption, physical security, and authentication - are all part of basic medical device cybersecurity best practices.

What Can Medical Device Manufacturers Learn from this Recall?

The first step would be to assess how secure by design your devices are. After the FDA’s 2026 guidance, there were major shifts in requirements for new devices. However, they don’t apply to legacy devices. You’re likely to have weaknesses there.

Something else to consider is reviewing SBOMs for all devices and ensuring you’re monitoring for vulnerabilities against code.

The third action step is to tighten up your device updates after they are in use to protect against new threats.

Finally, find a medical device cybersecurity expert to help you with the entire cybersecurity life cycle. This expertise could be the key to preventing an attack, breach, or removal of a device.

Get started by booking a consultation with our team today.

How Blue Goat approaches this

Blue Goat Cyber assists medical device manufacturers in avoiding costly recalls by embedding cybersecurity from the earliest design stages. Our approach integrates with your development lifecycle to identify and mitigate potential vulnerabilities before they become critical issues. We conduct thorough threat modeling, risk assessments, and penetration testing, informed by our team's deep expertise, including former CISSPs, OSCPs, and ex-military red team members.

We specialize in preparing manufacturers for FDA premarket submissions, ensuring all cybersecurity documentation, including SBOMs and security attestations, meets regulatory requirements. Our services focus on practical, actionable security measures tailored to your device's specific risk profile. If the FDA raises cybersecurity deficiencies after our submission, we resolve them at no additional cost. Partner with Blue Goat Cyber to ensure your devices are secure and compliant. Learn more about our services at [/services/fda-premarket-cybersecurity-services].

FAQ

What is secure by design in medical devices?

Secure by design is a proactive framework integrating security into a medical device's development lifecycle from the earliest stages. It ensures security is a core component, not an afterthought, aiming to mitigate vulnerabilities before they become exploitable.

How did secure by design fail in the ventilator recall?

The ventilator recall revealed failures like unencrypted data, exposed physical ports, and weak authentication. These issues suggest that basic security principles were not integrated into the design, indicating a lapse in the secure by design approach for the device.

Does the FDA require secure by design for medical devices?

Yes, the FDA strongly emphasizes secure by design principles in its February 3, 2026 final guidance for medical device cybersecurity. Manufacturers are expected to integrate security throughout the total product lifecycle.

What were the cybersecurity weaknesses found in the recalled ventilator?

The recalled ventilator had vulnerabilities such as unencrypted sensitive information, physically exposed ports allowing unauthorized access, and insufficient authentication for calibration and testing procedures.

What can manufacturers learn from this ventilator recall?

Manufacturers should assess the secure by design implementation for all devices, especially legacy models. They must also review SBOMs, monitor for vulnerabilities, and implement strong postmarket update processes to address evolving threats.

Can inadequate cybersecurity lead to a Class I recall?

Yes, inadequate cybersecurity that introduces risks to patient safety can lead to a Class I recall by the FDA. Such a recall indicates that device use could cause serious adverse health consequences or death, as was the case with this ventilator.

Related: Postmarket Cybersecurity for Medical Devices: The FDA Roadmap

About the author

Christian Espinosa, CISSP, Founder, Blue Goat Cyber. Christian leads a team focused exclusively on medical device cybersecurity for FDA premarket submissions and postmarket compliance. Read more about Christian.