FDA Device recall Z-1270-2025
Philips Connected Blood Glucose Meter, BGM 4
- FDA Device
- Class II
- ongoing
- Published 2025-03-12
On 2025-03-12 the FDA classified a Class II recall of Philips Connected Blood Glucose Meter, BGM 4 by Telcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1270-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-01-30 |
| Published | 2025-03-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Telcare |
| Distribution | US |
Product
Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;
Reason
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.
Identifiers
| code_info | Model Number: TM0009; UDI-DI: 00859519002407; Serial Numbers: Serial Numbers are formatted as TFXXXXXX or TGXXXXXX (X r…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1270-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.