Missed Recall Warnings: A Growing Safety Risk for Home Diabetes Device Users

Advances in home diabetes management technologies have transformed how millions of people manage their condition outside of traditional clinical settings. Devices such as insulin pumps, continuous glucose monitors (CGMs), and integrated systems that combine the two have enabled tighter glucose control, fewer manual interventions, and greater independence for patients. Closed-loop systems, in particular, represent a major step forward—automating insulin delivery based on real-time glucose data and significantly improving quality of life.

Yet as these technologies become more sophisticated and widely adopted, they also introduce new safety risks—especially when critical recall information, software updates, or safety warnings fail to reach patients and caregivers in a timely or understandable way. When recall communications break down, the consequences can be severe.

Why Recall Communication Matters More Than Ever

Unlike devices used exclusively in clinical settings, home diabetes technologies place significant responsibility on patients and caregivers. Users must monitor device performance, respond to alerts, install updates, and act on safety notices—often without immediate clinical oversight.

When recalls or safety updates are delayed, overlooked, misunderstood, or ignored, users may continue relying on devices that are functioning improperly or have known hazards. In the context of insulin delivery and glucose monitoring, even small errors can quickly escalate into medical emergencies.

Recent recall events highlight the seriousness of this risk. Examples include:

• Integrated insulin pump systems that could overdeliver insulin
• CGM sensors that may display incorrectly high glucose readings, masking hypoglycemia
• CGM receivers that fail to communicate alarms or alerts, or deliver them too late
• Insulin pumps affected by changes in air pressure, leading to unintended insulin delivery

Scenarios such as these posea direct threat to patient safety if users are unaware of the issue or do not understand how to respond appropriately.

The Clinical Consequences of Missed or Misunderstood Recalls

Failures in recall communication are not merely administrative lapses—they can have life-threatening clinical consequences. Malfunctions or inaccuracies in diabetes management devices can lead to hypoglycemia or hyperglycemia, both of which carry serious risks.

Hypoglycemia may result in confusion, seizures, loss of consciousness, or coma. Severe hyperglycemia can lead to diabetic ketoacidosis, hospitalization, and death if not treated promptly. Because these conditions can develop rapidly, timely awareness of device issues is critical.

For patients using automated or semi-automated systems, the danger may be compounded by overreliance on technology. When users trust that insulin delivery or glucose readings are accurate, they may be less likely to question results or intervene manually—especially if recall notifications are unclear or never received.

Why Recall Communication Fails

Recall communication failures can occur at multiple points along the information chain. Understanding these gaps is essential to improving safety.

Fragmented communication channels. Manufacturers may issue recall notices via email, postal mail, websites, or smartphone apps—but patients may not consistently receive or recognize these messages. Contact information may be outdated, messages may be filtered as spam, or notifications may be buried among routine app alerts.

In some cases, patients may not even realize they are affected by a recall if product identifiers, model numbers, or serial ranges are difficult to locate or interpret.

Complex or technical language. Even when recall notices reach users, the content itself may be a barrier. Technical jargon, dense explanations, or vague instructions can make it difficult for patients and caregivers to understand:

• Whether their device is affected
• What the actual risk is
• What actions they need to take—and how urgently

When recall instructions are confusing, users may delay action, take incorrect steps, or dismiss the notice entirely.

Limited clinical reinforcement. Healthcare providers may not always be aware of recalls affecting patients’ home devices, particularly when devices are obtained through third-party suppliers or managed primarily via manufacturer apps. As a result, patients may not receive reinforcement or clarification from clinicians—reducing the likelihood that they act promptly.

Shared Responsibility for Improving Recall Communication

Reducing harm from recall communication failures requires coordinated effort across the healthcare ecosystem. Patients, manufacturers, suppliers, and healthcare providers all play a role.

Supporting patients and caregivers. Patients and caregivers should be encouraged to take an active role in monitoring safety information related to their diabetes technologies. This includes:

• Registering devices and apps with manufacturers
• Keeping contact information up to date
• Paying close attention to alerts, notifications, and safety notices
• Knowing where to find recall and update information for their specific devices

Education should emphasize that recalls and updates are a routine part of medical device use—not a sign of failure, but a necessary safeguard.

Improving manufacturer communication. Manufacturers can reduce risk by ensuring that recall communications are clear, concise, and actionable. Effective notices should:

• Use plain language
• Clearly explain the potential harm
• Specify exactly which products are affected
• Provide step-by-step instructions for users
• Communicate urgency without causing unnecessary alarm

Using multiple communication channels—and repeating messages over time—can help ensure that critical information reaches users.

Strengthening the role of suppliers and providers. Medical equipment suppliers and healthcare providers are trusted sources of information and can reinforce recall messages. Establishing processes to notify patients during routine visits, telehealth appointments, or supply refills can help close communication gaps.

Clinicians should also feel empowered to discuss recalls openly with patients, helping them interpret notices and decide on appropriate next steps.

Building a Safer System for Home Diabetes Technologies

As diabetes care continues to move beyond clinical walls, patient safety depends increasingly on how well information flows to those using devices at home. Recall communication failures represent a systemic vulnerability—one that cannot be addressed through technology alone.

Clear communication, user-centered design, and shared accountability are essential. By improving how recall information is delivered, understood, and reinforced, the healthcare community can reduce preventable harm and support safer use of life-sustaining technologies.

Home diabetes management technologies offer tremendous benefits—but only when patients and caregivers are equipped with the timely, understandable safety information they need to use them safely.

Recall communication failures for home diabetes technologies are just one example of how gaps in health technology safety can put patients at risk.

ECRI’s Top 10 Health Technology Hazards for 2026 identifies the most urgent technology-related risks facing healthcare organizations—and offers practical insights to help leaders anticipate challenges, strengthen safety practices, and reduce harm.

Download complimentary Executive Brief of the report to learn about what health technology hazards demand the greatest attention in 2026. Members of ECRI programs can also access the full report, which details the steps your organization can take now to prepare.