Recall archive / FDA device enforcement

Philips Connected Blood Glucose Meter, BGM 4; Model Number: TM0009; — FDA record Z-1270-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jan 30, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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.
Classification: Class II
Recalling firm: Telcare, LLC
Quantity: 34,764 units
Agency-reported status: Ongoing
Source record identifier: Z-1270-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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, 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TF095365, TF095372, TF095376, TF095377, TF095378, TF095380, TF095382, TF095384, TF095385, TF095391, TF095392, TF095398, TF095404, TF095406, TF095408, TF095411, TF095413, TF095414, TF095415, TF095416, TF095417, TF095796, TF095818, TF095821, TF095830, TF095832, TF095835, TF095836, TF095838, TF095839, TF095840, TF095850, TF095854, TF095868, TF095869, TF095873, TF095644, TF095647, TF095657, TF095661, TF095665, TF095667, TF095669, TF095721, TF095726, TF095729, TF095739, TF095741, TF095747, TF095754, TF095756, TF095758, TF095760, TF095762, TF095765, TF095767, TF095774, TF095778, TF095781, TF095786, TF096858, TF089995, TF093323, TF093331, TF093332, TF093339, TF093343, TF093345, TF093361, TF093363, TF093364, TF093365, TF093366, TF093368, TF093370, TF093372, TF093382, TF093428, TF093432, TF093453, TF093454, TF093457, TF093402, TF093403, TF093404, TF093406, TF093407, TF093408, TF093412, TF093413, TF093421, TF093602, TF093603, TF093606, TF093619, TF093629, TF093632, TF093640, TF093642, TF093651, TF093652, TF093653, TF093655, TF093658, TF093659, TF093660, TF093673, TF093695, TF093699, TF093709, TF089684, TF089686, TF089659, TF089661, TF089665, TF089672, TF089678, TF089648, TF089652, TF089653, TF089655, TF089719, TF089720, TF089722, TF089723, TF089725, TF089726, TF089727, TF089728, TF089730, TF089734, TF089736, TF089737, TF089739, TF089747, TF089516, TF089518, TF089519, TF089511, TF089513, TF089689, TF089691, TF089694, TF089695, TF089697, TF089698, TF089699, TF089701, TF089714, TF089588, TF089589, TF089592, TF089594, TF089598, TF089604, TF089605, TF089606, TF089607, TF089608, TF089611, TF089612, TF089613, TF089614, TF089616, TF089618, TF089623, TF089624, TF089634, TF089640, TF089646, TF089467, TF089477, TF089480, TF089482, TF089483, TF089484, TF089485, TF089486, TF089487, TF089489, TF089490, TF089494, TF089496, TF089499, TF089504, TF089506, TF089561, TF089562, TF089563, TF089565, TF089568, TF089569, TF089570, TF089571, TF089572, TF089573, TF089524, TF089525, TF089527, TF089531, 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Label field

Details supplied by the agency

Lot, code or applicability

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, 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TF088891, TF088896, TF088905, TF088907, TF088940, TF088942, TF088944, TF088916, TF088921, TF088924, TF088926, TF088927, TF088928, TF088930, TF088934, TF084148, TF084150, TF084169, TF084179, TF084188, TF084201, TF084208, TF084194, TF084199, TF108746, TF108759, TF108768, TF108777, TF108788, TF108790, TF110105, TF110110, TF110115, TF110120, TF110813, TF110749, TF110757, TF110762, TF110775, TF110777, TF110780, TF110408, TF110414, TF110416, TF110419, TF110421, TF110426, TF110436, TF110443, TF110445, TF110454, TF110462, TF110483, TF110484, TF110485, TF110489, TF110500, TF110505, TF110511, TF110519, TF110531, TF110534, TF110536, TF110540, TF110954, TF110943, TF110935, TF110938, TF110949, TF110951, TF110880, TF110881, TF110883, TF110860, TF110862, TF110863, TF110864, TF110870, TF110877, TF110888, TF110892, TF110901, TF110903, TF110904, TF110905, TF110906, TF11090...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

US Nationwide distribution.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Mar 12, 2025
Recall initiation date: Jan 30, 2025
Center classification date: Mar 5, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

Related records