More than 38 million Americans are estimated to have diabetes—and every year 1.2 million people are diagnosed with the disease, according to the American Diabetes Association.

Even for some non-diabetics, monitoring blood sugar has become a modern way to gauge metabolic health that some health experts recommend (and should always be done under a physician’s guidance). For both diabetics and the blood glucose-conscious, continuous glucose monitoring systems, also known as CGMs, monitor blood sugar levels throughout the day. These products typically synch with a smart device and eliminate the need for finger pricks that are commonly associated with traditional blood glucose meters.

Though CGMs aim to simplify life for those with diabetes, a new warning indicates an error with one popular brand’s device could lead to serious health risks.

On Monday, June 16, the U.S. Food and Drug Administration (FDA) announced a nationwide recall of 639,269 Dexcom glucose receivers, affecting G6 and G7 versions. Both the G6 and G7 glucose receivers are part of continuous glucose monitoring systems, according to the Dexcom website. The receivers were also distributed internationally, with additional countries listed in the announcement.

Product details provided by the FDA are:

Dexcom G6 Glucose Receiver (36,824 total units recalled)

  • SKUs (Part Number): STK-FM-001 (MT27408-1) and STK-FR-001 (MT27408-1)
  • UDI (Unique Device Identification): STK-FM-001 – 00386270003232 and STK-FR-001 – 00386270003225

Dexcom G7 Glucose Receiver (602,445 total units recalled)

  • SKUs (Part Number):
    • STK-AT-011(MT26403-0)
    • STK-AT-012 (MT26403-0)
    • STK-AT-013 (MT26403-0)
    • STK-GT-001 (MT26403-1)
    • STK-GT-008 (MT26403-5)
    • STK-GT-013 (MT26403-1)
    • STK-GT-019 (MT26403-4)
    • STK-GT-100 (MT26403-2)
    • STK-GT-109 (MT26403-2)
    • STK-GT-113 (MT26403-3)
  • UDI:
    • STK-AT-011 – 00386270002198
    • STK-AT-012 -00386270002518
    • STK-AT-013 – 00386270002525
    • STK-GT-001 – 00386270004291
    • STK-GT-008 – 00386270004260
    • STK-GT-013 – 00386270002273
    • STK-GT-019 – 04595986293080
    • STK-GT-100 – 00386270002020
    • STK-GT-109 – 00386270002129
    • STK-GT-113 – 00386270003638

The recall reason is listed as “Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board.” The FDA report goes on to explain this issue is capable of “leading to missed audible alerts for low or high blood glucose values.” A missed alert for either low or high blood glucose levels could result in medical events such as seizures, vomiting, loss of consciousness, or even death, says the administration.

The maker Dexcom also provided details via an update, noting that the affected receivers “will still provide an alert through vibration and visual prompts. Other receiver and system functions, including accuracy, are not impacted.”

Dexcom says as of May, there have been 112 global consumer complaints related to the recall—and 56 “severe adverse events (including seizure, loss of consciousness, vomiting, or unspecified hypoglycemic/hyperglycemic symptoms),” though all affected individuals have reportedly recovered.

Though the recall was evidently first announced by Dexcom on May 12, the FDA last week officially designated the event as a Class I, the most severe classification. A Class I recall indicates the products involved could cause serious health issues or death.

Dexcom recommends users confirm whether their receiver is affected by looking up their serial number on their website. The above Dexcom link also provides contact information and tips for regular device testing.

If you or someone you know is experiencing a medical emergency, dial 911.

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