Philips BGM 4 Blood Glucose Meter Battery Expansion Risk Recall
Telcare recalls 34,764 Philips BGM 4 blood glucose meters (Model TM0009) nationwide due to battery expansion and swelling. The battery may cause the back cover to separate or, in worst-case scenarios, explode. No injuries reported to date.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with identified risk of battery explosion and serious injuries (eye injury, concussion, vision impairment) from projectiles, but no reported illnesses or injuries to date. Hazard identified through post-market surveillance remains theoretical in actual manifestation.
Plain-English summary
Telcare, LLC recalls 34,764 Philips Connected Blood Glucose Meter (BGM 4, Model TM0009) distributed nationwide due to battery expansion and swelling in the device.
The issue involves the meter's battery expanding, which can cause the removable back cover (battery port) to separate from the device. In worst-case scenarios, the battery may swell further and potentially explode. Exposure to such an explosion could create projectiles and pose health risks including eye injury, blurred vision, concussion, and dizziness.
If the back cover separates due to battery expansion, the device may lose primary function, preventing blood glucose measurement. This could delay treatment and lead to prolonged low or high blood sugar levels. While no injuries or device explosions have been reported to date, the defect has been identified through post-market surveillance and customer complaints.
Consumers with affected meters (Model TM0009, serial numbers starting with TF or TG) should check their device serial number and contact Telcare or their healthcare provider for guidance on replacement or remediation.
The recalled product
- Product
- Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009;
- Manufacturer
- Telcare, LLC
- Affected units
- 34,764
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model Number: TM0009
- UDI-DI: 00859519002407
- TF098191
- TF079123
- TF076786
- TF076836
- TF089080
- TF088984
- TF086097
- TF085390
- TF085029
- TF084238
- TF098751
- TF098975
- TF098976
- TF096704
- TF096961
- TF096966
- TF117862
- TF127077
Distribution
Distributed nationwide across the United States.
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