Almost 35,000 Blood Sugar Products Were Recalled Nationwide

As more Americans grow aware that blood sugar is an essential metric that helps determine metabolic health—meaning not just weight, but also risk of chronic conditions such as diabetes, heart, and stroke risk among others—more are getting curious about checking their own blood sugar.

And while continuous glucose monitoring products are becoming available without a prescription for the first time ever, some individuals are realizing that they can purchase finger-prick manual devices to keep track of their blood sugar themselves. If you’re one of them, or if you’re one of the 40 million Americans managing diabetes, lots of one blood sugar monitor are being called off the market.

The U.S. Food and Drug Administration (FDA) recently announced a nationwide recall of 34,764 Philips Connected Blood Glucose Meters. This Wednesday, the agency’s notice was updated to identify it as a Class II recall, meaning the blood glucose meters could “cause temporary or medically reversible adverse health effects.”

The recalled blood glucose meter details include:

• Philips Connected Blood Glucose Meter, BGM 4
• Model Number: TM0009
• UDI-DI (Unique Device Identifier-Device Identifier): 00859519002407

In addition, the FDA noted the recalled serial numbers are formatted as TFXXXXXX or TGXXXXXX (X represents digits). The recalled serial numbers list is expansive and can be found in full here.

The FDA indicates the recall was initiated due to customer complaints of “battery expansion/swelling,” going on to say “events of battery expansion/swelling and associated symptoms, e.g., leading to the device’s removable back cover (battery port) to separate.” The notice speaks to a “worst-case situation” for the battery swelling to “result in explosion of the battery and/or device.” The FDA notes that an explosion could create projectiles from the device, leading to potential health risks such as concussion, headache, dizziness, eye irritation, blurred vision, eye injury, and vision.

It’s also important to understand that because the malfunction could potentially result in a loss of device function, the FDA warns “an immediate health consequence that may result is prolonged hypoglycemia or hyperglycemia due to delay in treatment, as the blood glucose measurement is not available to guide treatment.”

The recalling firm is listed as Telcare, LLC in Concord, MA. The Telcare portal website lists “Telcare LLC, BioTelemetry, a Philips company.” A 2021 press release lists BioTelemetry as a newly acquired company by Philips.

According to an online product manual, the Philips Connected Blood Glucose Meter is part of the Philips Connected Blood Glucose Monitoring System, which also contains Philips Test Strips and Philips Control Solutions (which confirms the blood glucose meter and test strips are working correctly).

It is not immediately clear if the Philips Connected Blood Glucose Meter is available to buy from major retailers, though the Philips/BioTel Care website does have a subscription service via its website. A brief search on both the Philips and Telcare websites did not provide additional recall information as of Thursday afternoon.