FDA Medical devices recall · March 12, 2025

Philips Connected Blood Glucose Meter, BGM 4 recall

Read the official FDA notice ↗

Product

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

Why was it 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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Model Number: TM0009; UDI-DI: 00859519002407; Serial Numbers: Serial Numbers are formatted as TFXXXXXX or TGXXXXXX (X represents digits). Meter Serial Numbers: TF048802, TF098191, TF079123, TF076786, TF076836, TF089080, TF088984, TF086097, TF085390, TF085029, TF084238, TF098751, TF098975, TF098976, TF096704, TF096961, TF096966, TF117862, TF127077, TF049583, TF047153, TF063135, TF127267, TF100376, TF086287, TF104396, TF104399, TF104401, TF104403, TF104404, TF104405, TF104407, TF104408, TF104409, TF104410, TF104411, TF104412, TF104414, TF104415, TF104416, TF104417, TF104418, TF104421, TF104426, TF104427, TF104428, TF104429, TF104430, TF104431, TF104432, TF104433, TF104439, TF104440, TF104441, TF104442, TF104444, TF104446, TF104448, TF104449, TF104452, TF104453, TF104454, TF104455, TF104456, TF104458, TF104460, TF104461, TF104462, TF104467, TF104468, TF104469, TF104471, TF104473, TF104474, TF104479, TF104480, TF104481, TF104482, TF104483, TF104486, TF104487, TF104490, TF104491, TF104492, TF104494, TF104496, TF104498, TF104500, TF104501, TF104503, TF104505, TF104506, TF104510, TF104511, TF104512, TF104514, TF104516, TF104520, TF104521, TF104522, TF104525, TF104526, TF104527, TF104528, TF104529, TF104530, TF104534, TF104535, TF104537, TF104538, TF104541, TF104545, TF104554, TF104555, TF104566, TF104567, TF104568, TF104570, TF104571, TF104573, TF104576, TF104577, TF104579, TF104581, TF104585, TF104586, TF104588, TF104589, TF104590, TF104592, TF104593, TF104595, TF104599, TF104601,

Distribution

US Nationwide distribution.

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (medical devices), recall Z-1270-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.