Telcare, LLC recalls Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;

Recall date

January 30, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1270-2025

FDA classification

Class II

Brand / firm

Telcare, LLC

Sold / distributed

US Nationwide distribution.

Why it was recalled

Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System.. The issue was identified by post market surveillance data (customer complaints) - events of battery expansion/swelling and associated symptoms, e.g., leading to the device's removable back cover (battery port) to separate. If there is a loss of primary function of the device due to the described device defect, 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. In a worst-case situation, there is potential for battery swelling to result in explosion of the battery and/ or device. Exposure to explosion, and subsequently projectiles from the explosion, may result in several immediate health consequences, including concussion, headache, dizziness, eye irritation, blurred vision, eye injury, and vision impairment.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;