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RecallWatchMedical Device Safety
Class IIOngoingZ-1270-2025

Telcare, LLC recalls Philips Connected Blood Glucose Meter

Telcare, LLCConcord, MA, United StatesReported Mar 12, 2025 · 1 year ago
Legal News Analyst ·

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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

Lot / code information

Model
TM0009
UDI
00859519002407
Serial #
are formatted as TFXXXXXX or TGXXXXXX (X represents digits). Meter
Serial #
TF048802, TF098191, TF079123, TF076786, TF076836, TF089080 — +3238 moreShow all
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…
Additional code information

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TF045665, TF045668, TF045614, TF045619, TF045620, TF045623, TF045675, TF045679, TF045680, TF045685, TF045690, TF045691, TF045694, TF045696, TF045700, TF045704, TF045706, TF045030, TF045088, TF045090, TF045308, TF045317, TF045321, TF045323, TF045324, TF045325, TF045330, TF045335, TF045336, TF045337, TF045338, TF045340, TF045341, TF045342, TF045344, TF045345, TF045346, TF045347, TF045351, TF045354, TF045083, TF045084, TF045101, TF045106, TF045107, TF045114, TF045115, TF045118, TF045121, TF045123, TF045135, TF046149, TF046221, TF046222, TF046252, TF046027, TF046071, TF046077, TF046108, TF045884, TF045917, TF045956, TF045996, TF046011, TF045937, TF045798, TF045822, TF046878, TF046880, TF046888, TF046950, TF046979, TF046933, TF046811, TF046704, TF046727, TF046697, TF046829, TF046820, TF046737, TF046863, TF047047, TF047051, TF047197, TF047208, TF047194, TF047183, TF047135, TF047129, TF047121, TF047122, TF047171, TF047148, TF046524, TF046533, TF046541, TF046544, TF046545, TF046555, TF046566, TF046576, TF046595, TF046584, TF046693, TF046662, TF046792, TF046473, TF046485, TF046505, TF046439, TF046399, TF046409, TF046295, TF046366, TF046382, TF046380, TF045144, TF045146, TF045147, TF045151, TF045157, TF045160, TF045164, TF045165, TF045166, TF045169, TF045172, TF045179, TF045180, TF045182, TF045185, TF045191, TF045196, TF045200, TF045201, TF045205, TF045206, TF045209, TF045219, TF045227, TF045230, TF045233, TF045237, TF045245, TF045251, TF045255, TF045259, TF045262, TF045271, TF045280, TF045281, TF045288, TF045001, TF045003, TF045005, TF044929, TF045007, TF045008, TF045014, TF045019, TF045021, TF045025, TF044843, TF044872, TF044893, TF044951, TF044952, TF044953, TF044956, TF044961, TF044962, TF044967, TF044969, TF044976, TF044980, TF044676, TF044677, TF044700, TF044726, TF044711, TF044713, TF044694, TF044719, TF044806, TF044807, TF044811, TF044823, TF044845, TF044859, TF044879, TF044621, TF044631, TF044632, TF044640, TF044525, TF044538, TF044528, TF044479, TF044480, TF044497, TF044487, TF044433, TF044235, TF044273, TF044258, TF044248, TF044252, TF044301, TF044311, TF044286, TF044402, TF044391, TF042935, TF042936, TF042944, TF043059, TF043377, TF043380, TF043386, TF043388, TF043389, TF043390, TF043391, TF043352, TF043353, TF043356, TF043370, TF043329, TF043325, TF043475, TF043456, TF043471, TF043453, TF043458, TF043383, TF043410, TF043423, TF043424, TF043428, TF043433, TF043437, TF044158, TF044160, TF043975, TF043979, TF043981, TF043983, TF043985, TF043988, TF043991, TF043994, TF043996, TF043999, TF044022, TF044025, TF044028, TF044038, TF044040, TF044041, TF044042, TF044043, TF044044, TF044047, TF044048, TF044052, TF044053, TF044061, TF044062, TF044066, TF044067, TF044071, TF044075, TF044076, TF044082, TF044084, TF044095, TF044099, TF044105, TF044106, TF044107, TF044111, TF044112, TF044113, TF044115, TF044117, TF044118, TF044120, TF044125, TF044134, TF044141, TF044148, TF043704, TF043662, TF043596, TF043591, TF043606, TF058852, TF057748, TF056597, TF056599, TF056603, TF056604, TF056610, TF056612, TF056614, TF056616, TF056623, TF056629, TF056630, TF056631, TF056634, TF056669, TF056710, TF056687, TF056750, TF056754, TF056760, TF056772, TF056888, TF056889, TF056892, TF056897, TF056903, TF056904, TF056906, TF056913, TF056917, TF056918, TF056922, TF056925, TF056936, TF056938, TF056939, TF056944, TF056945, TF056946, TF056952, TF056956, TF056960, TF056837, TF056839, TF056843, TF056757, TF056770, TF056789, TF056795, TF056796, TF056826, TF056856, TF056867, TF056871, TF056873, TF056879, TF056881, TF056882, TF056977, TF056978, TF057013, TF057016, TF057018, TF057020, TF057021, TF057026, TF057030, TF057036, TF057038, TF057041, TF057044, TF057045, TF057048, TF057051, TF057056, TF057058, TF057073, TF057074, TF057075, TF057077, TF057083, TF057173, TF057161, TF057162, TF057163, TF057146, TF057119, TF057089, TF057114, TF057093, TF057094, TF057096, TF057097, TF056988, TF056989, TF056966, TF056991, TF056995, TF056997, TF056998, TF056999, TF057001, TF057002, …

What the firm is doing

On January 30, 2025, an IMPORTANT Safety Notification message was pushed out to display on all meter devices. IMPORTANT Safety Notification: https://www.gobio.com/bgm - information on proper battery use. Mensaje importante sobre batera. What you should do: If you have a Philips or BioTel charger and your meter is working normally, you can keep using it. If you experience any of these issues, stop using your meter and contact Philips Customer Service at (888) 666-4530 (US) or (1) (978) 610-4688 (International): 1. The meter looks damaged or cracked. 2. The meter is swollen. 3. The meter is too hot to hold. 4. The meter won t hold a charge. 5. You don t have the Philips or BioTel charger. How to Charge your meter safely: 1. Only use the USB cable and power adapter that were included in your kit. They are blue and branded with Philips or BioTel. 2. Keep the meter and cables away from water. 3. Store the meter between 10C and 40C (50F and 104F). 4. Keep the meter and cables clean and dry. Make sure to follow these guidelines to prevent battery issues. What Philips is doing: Philips will update you on how to improve the battery usage as soon as possible. We also encourage you to perform a Meter Replacement Check to determine if your device is working properly. Safety and quality are our top priorities. For more information or support, call Philips Customer Service at (888) 666-4530 (US) or (1) (978) 610-4688 (International), Monday Friday from 9:00 AM to 9:00 PM Eastern Time, excluding major holidays. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax: 1. Complete and submit the report Online. 2. Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (1-800-332-0178).

DistributionShow details

US Nationwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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