What to Do if Your Dexcom Is Recalled: A Step-by-Step Guide for Patients Navigating Recalls

Medical technology has changed the way people manage chronic conditions like diabetes. Continuous glucose monitors (CGMs), such as those produced by Dexcom, provide real-time data that helps patients avoid dangerous highs and lows. 

But like any medical device, Dexcom products are not immune to defects. When a defect poses a risk to patient safety, the U.S. Food and Drug Administration (FDA) or the manufacturer may issue a recall.

If you or a loved one relies on Dexcom and recently learned about a recall, you may be left feeling uncertain about what to do next. This step-by-step guide will walk you through the process, from confirming whether your device is affected to replacing it and protecting your legal rights.

Understanding Medical Device Recalls

A medical device recall occurs when a manufacturer or the FDA identifies a problem with a product that could put patients at risk. Recalls don’t always mean that every product must be returned or discontinued. Sometimes they involve updated instructions, replacement parts, or safety warnings.

Dexcom, like other medical device manufacturers, has issued recalls in the past. Reasons for a recall can include:

• Defective sensors or transmitters that provide inaccurate glucose readings.
• Adhesive or packaging problems that make the product unsafe or ineffective.
• Software glitches that impact the accuracy of data transmission.
• Battery or charging issues that may cause the device to stop working unexpectedly.

Because Dexcom products play a critical role in daily diabetes management, any malfunction can carry serious consequences, including hypoglycemia, hyperglycemia, diabetic ketoacidosis (DKA), and other injuries.

Step 1: Confirm Whether Your Dexcom Device Is Affected

The first step in handling a potential recall is determining whether your device is included. Here’s how:

1. Check the FDA’s Recalls Database

Visit the FDA Medical Device Recalls Database and search for “Dexcom.” Look for the most recent recall notices and see if your product model, lot number, or manufacturing dates are listed.

 

2. Review Dexcom’s Official Recall Announcements

Dexcom typically issues recall notices on its website or through press releases. Check the “Support” or “Newsroom” sections of Dexcom’s site for updates.

 

3. Examine Your Device Packaging and Labels

Most recalls will specify affected lot numbers, serial numbers, or expiration dates. Compare this information with what is printed on your device, packaging, or the Dexcom app.

 

4. Contact Your Pharmacy or Medical Supplier

If you received your Dexcom through a pharmacy, durable medical equipment supplier, or mail-order service, ask whether the device you were sent is part of the recall.

 

5. Talk to Your Doctor or Diabetes Educator

Your healthcare team may have been notified about the recall directly and can help verify whether your specific model is impacted.

 

Step 2: Follow Dexcom’s Instructions for Replacement or Repair

Once you confirm that your Dexcom is affected, the next step is to follow the recall instructions provided by Dexcom or the FDA. Typically, this involves:

1. Stopping Use of the Defective Device

If the recall notice indicates that continued use is unsafe, stop using the device immediately. Switch to an alternative monitoring method, such as fingerstick glucose testing, until a safe replacement is available.

 

2. Registering for a Replacement

Dexcom usually provides a recall hotline or an online form where you can submit your device information to request a replacement.  You may need to provide the serial number, lot number, or purchase details.

 

3. Returning the Defective Device (If Required)

Some recalls require you to return the defective product. Dexcom may provide a prepaid shipping label or instructions on how to dispose of the product safely.

 

4. Tracking Your Replacement Shipment

Keep a record of your replacement request and follow up if you don’t receive confirmation within the expected timeframe.

 

5. Updating Insurance or Pharmacy Records

If you received your Dexcom through insurance, notify your provider about the recall to avoid coverage issues when ordering a replacement.

 

Step 3: Protect Your Health in the Interim

While waiting for a replacement device, your priority should be maintaining safe blood glucose monitoring. Here’s how to protect your health:

• Revert to Fingerstick Testing: Use a traditional glucometer and test strips to monitor your blood sugar. While less convenient, it provides reliable readings.
• Check More Frequently: If you were used to continuous monitoring, adjust your routine to test more often, especially before meals, bedtime, and physical activity.
• Keep Backup Supplies Handy: Make sure you have enough lancets, test strips, and batteries for your glucometer.
• Watch for Symptoms of Low or High Blood Sugar: Fatigue, shakiness, confusion, extreme thirst, or frequent urination may signal unsafe levels.
• Stay in Touch With Your Doctor: If your replacement is delayed or you notice changes in your glucose patterns, contact your healthcare provider right away.
  
   

Step 4: Document Everything

If a recalled Dexcom device caused you harm or even if you just had to go through the replacement process, it’s important to document the experience. This can help both your healthcare team and, if necessary, your attorney.

Keep a record of:

• The recall notice you received, including dates and reference numbers.
• Device details, such as model, lot number, and purchase date.
• Communications with Dexcom or your supplier (emails, letters, call logs).
• Medical records, including any hospital visits or blood sugar events linked to the defective device.
• Expenses incurred, such as costs for backup testing supplies, lost workdays, or emergency care.

This documentation may become critical if you later pursue a legal claim.

Step 5: Understand Your Legal Rights

Medical device manufacturers have a duty to ensure their products are safe for use. When a defective product reaches patients and causes harm, those affected may have legal grounds for compensation.

When You Might Have a Claim

You may be entitled to file a lawsuit if a defective Dexcom device caused:

• Severe hypoglycemia or hyperglycemia due to inaccurate readings.
• Hospitalization or emergency treatment.
• Long-term health complications, such as diabetic ketoacidosis, seizures, or comas.
• Financial losses from medical bills, lost income, or replacement costs.
• Emotional distress related to device failure.
  
   

Possible Legal Theories

• Product Liability: Holding Dexcom accountable for manufacturing defects, design flaws, or inadequate warnings.
• Negligence: Arguing that Dexcom failed to exercise reasonable care in the production or distribution of the device.
• Breach of Warranty: If the product failed to perform as advertised or expected.
  
   

Types of Compensation Available

• Medical expenses (current and future).
• Lost wages and reduced earning capacity.
• Pain and suffering.
• Out-of-pocket costs related to device replacement.
• In some cases, punitive damages if gross negligence is proven.
  
   

Step 6: Contact an Experienced Attorney

Navigating a medical device recall can be overwhelming, especially if you’ve been harmed by the product. An experienced attorney can help you:

• Determine whether you have a valid claim.
• File within the statute of limitations before your claim expires.
• Collect medical and financial evidence to support your case.
• Negotiate with Dexcom or their insurers for fair compensation.
• Represent you in court if a settlement cannot be reached.

At Morgan & Morgan, our attorneys have extensive experience handling defective medical device cases. We understand how devastating it can be when the very device meant to protect your health puts you in danger instead.

Step 7: Stay Informed About Future Recalls

Unfortunately, recalls are not uncommon in the medical device industry. To stay proactive:

• Subscribe to FDA Recall Alerts: Sign up for email updates on recalls that may affect your health.
• Register Your Devices: Always register your Dexcom products with the manufacturer so you receive direct recall notifications.
• Check Regularly for Safety Notices: Periodically visit Dexcom’s website or FDA’s recall database.
• Stay Engaged With Your Healthcare Team: Your doctor may hear about recalls before the general public and can alert you promptly.
  
   

Morgan & Morgan Can Help

A Dexcom recall can be stressful, but taking the right steps can protect both your health and your legal rights. Start by confirming whether your device is affected, following Dexcom’s replacement instructions, and using safe backup methods in the meantime. Keep thorough documentation of your experience, and don’t hesitate to seek legal help if you’ve been harmed by a defective device.

If you or a loved one suffered due to a recalled Dexcom product, you don’t have to go through this alone. At Morgan & Morgan, we fight for patients whose trust in medical technology has been broken. Our attorneys are here to help you pursue the compensation you deserve.

Hiring one of our lawyers is easy, and you can get started in minutes with a free case evaluation.