Philips Connected Blood Glucose Meter — Class II medical device recall Z-1270-2025
Ongoing recall by Telcare, LLC, reported 2025-03-12, distributed nationwide. Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected
| Recall number | Z-1270-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Telcare, LLC, Concord, MA, United States |
| Recall initiated | 2025-01-30 |
| Classified | 2025-03-05 |
| Reported by FDA | 2025-03-12 |
| Distributed | Nationwide (US) |
| Quantity | 34,764 units |
| UPC / GTIN / UDI-DI | 00859519002407 |
| Serial numbers | TF000814, TF000831, TF001299, TF001368, TF001370, TF001513, TF001666, TF001677, TF001678, TF001692, TF001703, TF001729, TF001744, TF001785, TF001800, TF001802, TF001821, TF001824, TF001847, TF001879, TF001881, TF001909, TF001921, TF001928, TF002777 and 475 more |
| Model numbers | TM0009 |
Product
Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1270-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.