CLASS II ONGOING Device recall · Reported 12 Jul 2023 · FDA Enforcement Report

Trackmaster, Treadmill Tmx428 220v recalled by Full Vision

Full Vision is recalling Trackmaster, Treadmill Tmx428 220v, distributed nationwide in the US. The recall was initiated on 12 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 00860176000613, Serial Numbers: FVDC-7630, FVDC-7631, FVDC-7633, FVDC-7634, FVDC-7635, FVDC-7636, FVDC-7637, FVDC-7638, FVDC-7639, FVDC-7647, FVDC-7648, FVDC-7649, FVDC-7650, FVDC-7651, FVDC-7652, FVDC-7653, FVDC-7654, FVDC-7655, FVDC-7656, FVDC-7657, FVDC-7658, FVDC-7659, FVDC-7660, FVDC-7661, FVDC-7662, FVDC-7663, FVDC-7664, FVDC-7665, FVDC-7707, FVDC-7708, FVDC-7709, FVDC-7710, FVDC-7711, FVDC-7712, FVDC-7713, FVDC-7714, FVDC-7715, FVDC-7716, FVDC-7749, FVDC-7750, FVDC-7751, FVDC-7752, FVDC-7753, FVDC-7754, FVDC-7755, FVDC-7756, FVDC-7757, FVDC-7758, FVDC-7759, FVDC-7760, FVDC-7761, FVDC-7762, FVDC-7763, FVDC-7764, FVDC-7765, FVDC-7766, FVDC-7767, FVDC-7768, FVDC-7769, FVDC-7770, FVDC-7771, FVDC-7772, FVDC-7773, FVDC-7774, FVDC-7775, FVDC-7776, FVDC-7777, FVDC-7778, FVDC-7779, FVDC-7780, FVDC-7784, FVDC-7801, FVDC-7802, FVDC-7803, FVDC-7804, FVDC-7805, FVDC-7806, FVDC-7807, FVDC-7808, FVDC-7809, FVDC-7810, FVDC-7826, FVDC-7827, FVDC-7828, FVDC-7829, FVDC-7830, FVDC-7831, FVDC-7832, FVDC-7833, FVDC-7834, FVDC-7835, FVDC-7851, FVDC-7852, FVDC-7853, FVDC-7854, FVDC-7855, FVDC-7856, FVDC-7857, FVDC-7858, FVDC-7859, FVDC-7860, FVDC-7861, FVDC-7862, FVDC-7863, FVDC-7900, FVDC-7901, FVDC-7902, FVDC-7903, FVDC-7904, FVDC-7905, FVDC-7906, FVDC-7907, FVDC-7908, FVDC-7909, FVDC-7910, FVDC-7911, FVDC-7912, FVDC-7913, FVDC-7914, FVDC-7928, FVDC-7929, FVDC-7930, FVDC-7931, FVDC-7932, FVDC-7933, FVDC-7934, FVDC-7935, FVDC-7936, FVDC-7937, FVDC-7938, FVDC-7939, FVDC-7940, FVDC-7941, FVDC-7942, FVDC-7948, FVDC-7949, FVDC-7950, FVDC-7951, FVDC-7952, FVDC-7953, FVDC-7954, FVDC-7955, FVDC-7956, FVDC-7957, FVDC-7967, FVDC-7968, FVDC-7969, FVDC-7970, FVDC-7971, FVDC-7972, FVDC-7973, FVDC-7974, FVDC-7975, FVDC-7976, FVDC-7977, FVDC-7978, FVDC-7979, FVDC-7980, FVDC-7981, FVDC-7982, FVDC-7996, FVDC-7997, FVDC-7998, FVDC-7999, FVDC-8000, FVDC-8026, FVDC-8027, FVDC-8028, FVDC-8064, FVDC-8065, FVDC-8066, FVDC-8067, FVDC-8068, FVDC-8108, FVDC-8109, FVDC-8126, FVDC-8157, FVDC-8158, FVDC-8159, FVDC-8160, FVDC-8161, FVDC-8162, FVDC-8163, FVDC-8164, FVDC-8165, FVDC-8166, FVDC-8172, FVDC-8173, FVDC-8174, FVDC-8175, FVDC-8176, FVDC-8177, FVDC-8178, FVDC-8179, FVDC-8180, FVDC-8181, FVDC-8182, FVDC-8183, FVDC-8184, FVDC-8185, FVDC-8190, FVDC-8191, FVDC-8203, FVDC-8204, FVDC-8205, FVDC-8206, FVDC-8207, FVDC-8208, FVDC-8209, FVDC-8210, FVDC-8211, FVDC-8212, FVDC-8235, FVDC-8236, FVDC-8237, FVDC-8238, FVDC-8239, FVDC-8240, FVDC-8241, FVDC-8242, FVDC-8243, FVDC-8244, FVDC-8267, FVDC-8268, FVDC-8270, FVDC-8271, FVDC-8311, FVDC-8312, FVDC-8313, FVDC-8314, FVDC-8315, FVDC-8356, FVDC-8357, FVDC-8358, FVDC-8359, FVDC-8360, FVDC-8361, FVDC-8362, FVDC-8363, FVDC-8364, FVDC-8365, FVDC-8366, FVDC-8367, FVDC-8368, FVDC-8369, FVDC-8370, FVDC-8371, FVDC-8372, FVDC-8373, FVDC-8374, FVDC-8375, FVDC-8376, FVDC-8377, FVDC-8378, FVDC-8379, FVDC-8380, FVDC-8381, FVDC-8382, FVDC-8383, FVDC-8384, FVDC-8385, FVDC-8390, FVDC-8391, FVDC-8392, FVDC-8411, FVDC-8417, FVDC-8418, FVDC-8419, FVDC-8436, FVDC-8437, FVDC-8438, FVDC-8439, FVDC-8440, FVDC-8441, FVDC-8442, FVDC-8443, FVDC-8444, FVDC-8445, FVDC-8466, FVDC-8467, FVDC-8468, FVDC-8469, FVDC-8470, FVDC-8471, FVDC-8472, FVDC-8473, FVDC-8474, FVDC-8475, FVDC-8476, FVDC-8477, FVDC-8478, FVDC-8479, FVDC-8480, FVDC-8481, FVDC-8482, FVDC-8483, FVDC-8509, FVDC-8510, FVDC-8511, FVDC-8512, FVDC-8513, FVDC-8529, FVDC-8530, FVDC-8531, FVDC-8540, FVDC-8552, FVDC-8574, FVDC-8575, FVDC-8576, FVDC-8577, FVDC-8578, FVDC-8579, FVDC-8580, FVDC-8581, FVDC-8582, FVDC-8583, FVDC-8584, FVDC-8585, FVDC-8586, FVDC-8587, FVDC-8588, FVDC-8589, FVDC-8590, FVDC-8591, FVDC-8592, FVDC-8593, FVDC-8594, FVDC-8595, FVDC-8596, FVDC-8597, FVDC-8598, FVDC-8635, FVDC-8636, FVDC-8637, FVDC-8638, FVDC-8639, FVDC-8640, FVDC-8641, FVDC-8642, FVDC-8643, FVDC-8644, FVDC-8647, FVDC-8649, FVDC-8650, FVDC-8664, FVDC-8665, FVDC-8666, FVDC-8667, FVDC-8668, FVDC-8669, FVDC-8670, FVDC-8671, FVDC-8672, FVDC-8673, FVDC-8684, FVDC-8685, FVDC-8686, FVDC-8687, FVDC-8688, FVDC-8689, FVDC-8690, FVDC-8691, FVDC-8692, FVDC-8693, FVDC-8694, FVDC-8695, FVDC-8696, FVDC-8727, FVDC-8728, FVDC-8729, FVDC-8764, FVDC-8765, FVDC-8766, FVDC-8767, FVDC-8807, FVDC-8808

Quantity recalled376 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2053-2023
FDA event ID: 92382
Recalling firm: Full Vision, Newton, KS
Classification: Class II
Status: Ongoing
Recall initiated: 12 May 2023
FDA classified: 30 Jun 2023
Reported: 12 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

12 May 2023	Recall initiated by company
30 Jun 2023	Classified by FDA	+49 days
12 Jul 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

TRACKMASTER, TREADMILL TMX428 220V, MODEL NUMBER 317-07927

Where it was distributed

USA (Nationwide), Australia, Bahrain, Canada, Chile, Colombia, Costa Rica, Dominican Republic, FINLAND, Guatemala, HONG KONG, India, Indonesia, Israel, Mexico, NEW ZEALAND, Nicaragua, Panama, PARAQUAY, Peru, Philippines, Saudi Arabia, Singapore, SOUTH KOREA, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uruguay

Nationwide

Questions about this recall

Is Trackmaster, Treadmill Tmx428 220v recalled?

Yes. Full Vision recalled Trackmaster, Treadmill Tmx428 220v on 12 May 2023. The recall is Class II and its status is Ongoing. Recall number Z-2053-2023.

Why was it recalled?

Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.

Which lots are affected?

UDI/DI 00860176000613, Serial Numbers: FVDC-7630, FVDC-7631, FVDC-7633, FVDC-7634, FVDC-7635, FVDC-7636, FVDC-7637, FVDC-7638, FVDC-7639, FVDC-7647, FVDC-7648, FVDC-7649, FVDC-7650, FVDC-7651, FVDC-7652, FVDC-7653, FVDC-7654, FVDC-7655, FVDC-7656, FVDC-7657, FVDC-7658, FVDC-7659, FVDC-7660, FVDC-7661, FVDC-7662, FVDC-7663, FVDC-7664, FVDC-7665, FVDC-7707, FVDC-7708, FVDC-7709, FVDC-7710, FVDC-7711, FVDC-7712, FVDC-7713, FVDC-7714, FVDC-7715, FVDC-7716, FVDC-7749, FVDC-7750, FVDC-7751, FVDC-7752, FVDC-7753, FVDC-7754, FVDC-7755, FVDC-7756, FVDC-7757, FVDC-7758, FVDC-7759, FVDC-7760, FVDC-7761, FVDC-7762, FVDC-7763, FVDC-7764, FVDC-7765, FVDC-7766, FVDC-7767, FVDC-7768, FVDC-7769, FVDC-7770, FVDC-7771, FVDC-7772, FVDC-7773, FVDC-7774, FVDC-7775, FVDC-7776, FVDC-7777, FVDC-7778, FVDC-7779, FVDC-7780, FVDC-7784, FVDC-7801, FVDC-7802, FVDC-7803, FVDC-7804, FVDC-7805, FVDC-7806, FVDC-7807, FVDC-7808, FVDC-7809, FVDC-7810, FVDC-7826, FVDC-7827, FVDC-7828, FVDC-7829, FVDC-7830, FVDC-7831, FVDC-7832, FVDC-7833, FVDC-7834, FVDC-7835, FVDC-7851, FVDC-7852, FVDC-7853, FVDC-7854, FVDC-7855, FVDC-7856, FVDC-7857, FVDC-7858, FVDC-7859, FVDC-7860, FVDC-7861, FVDC-7862, FVDC-7863, FVDC-7900, FVDC-7901, FVDC-7902, FVDC-7903, FVDC-7904, FVDC-7905, FVDC-7906, FVDC-7907, FVDC-7908, FVDC-7909, FVDC-7910, FVDC-7911, FVDC-7912, FVDC-7913, FVDC-7914, FVDC-7928, FVDC-7929, FVDC-7930, FVDC-7931, FVDC-7932, FVDC-7933, FVDC-7934, FVDC-7935, FVDC-7936, FVDC-7937, FVDC-7938, FVDC-7939, FVDC-7940, FVDC-7941, FVDC-7942, FVDC-7948, FVDC-7949, FVDC-7950, FVDC-7951, FVDC-7952, FVDC-7953, FVDC-7954, FVDC-7955, FVDC-7956, FVDC-7957, FVDC-7967, FVDC-7968, FVDC-7969, FVDC-7970, FVDC-7971, FVDC-7972, FVDC-7973, FVDC-7974, FVDC-7975, FVDC-7976, FVDC-7977, FVDC-7978, FVDC-7979, FVDC-7980, FVDC-7981, FVDC-7982, FVDC-7996, FVDC-7997, FVDC-7998, FVDC-7999, FVDC-8000, FVDC-8026, FVDC-8027, FVDC-8028, FVDC-8064, FVDC-8065, FVDC-8066, FVDC-8067, FVDC-8068, FVDC-8108, FVDC-8109, FVDC-8126, FVDC-8157, FVDC-8158, FVDC-8159, FVDC-8160, FVDC-8161, FVDC-8162, FVDC-8163, FVDC-8164, FVDC-8165, FVDC-8166, FVDC-8172, FVDC-8173, FVDC-8174, FVDC-8175, FVDC-8176, FVDC-8177, FVDC-8178, FVDC-8179, FVDC-8180, FVDC-8181, FVDC-8182, FVDC-8183, FVDC-8184, FVDC-8185, FVDC-8190, FVDC-8191, FVDC-8203, FVDC-8204, FVDC-8205, FVDC-8206, FVDC-8207, FVDC-8208, FVDC-8209, FVDC-8210, FVDC-8211, FVDC-8212, FVDC-8235, FVDC-8236, FVDC-8237, FVDC-8238, FVDC-8239, FVDC-8240, FVDC-8241, FVDC-8242, FVDC-8243, FVDC-8244, FVDC-8267, FVDC-8268, FVDC-8270, FVDC-8271, FVDC-8311, FVDC-8312, FVDC-8313, FVDC-8314, FVDC-8315, FVDC-8356, FVDC-8357, FVDC-8358, FVDC-8359, FVDC-8360, FVDC-8361, FVDC-8362, FVDC-8363, FVDC-8364, FVDC-8365, FVDC-8366, FVDC-8367, FVDC-8368, FVDC-8369, FVDC-8370, FVDC-8371, FVDC-8372, FVDC-8373, FVDC-8374, FVDC-8375, FVDC-8376, FVDC-8377, FVDC-8378, FVDC-8379, FVDC-8380, FVDC-8381, FVDC-8382, FVDC-8383, FVDC-8384, FVDC-8385, FVDC-8390, FVDC-8391, FVDC-8392, FVDC-8411, FVDC-8417, FVDC-8418, FVDC-8419, FVDC-8436, FVDC-8437, FVDC-8438, FVDC-8439, FVDC-8440, FVDC-8441, FVDC-8442, FVDC-8443, FVDC-8444, FVDC-8445, FVDC-8466, FVDC-8467, FVDC-8468, FVDC-8469, FVDC-8470, FVDC-8471, FVDC-8472, FVDC-8473, FVDC-8474, FVDC-8475, FVDC-8476, FVDC-8477, FVDC-8478, FVDC-8479, FVDC-8480, FVDC-8481, FVDC-8482, FVDC-8483, FVDC-8509, FVDC-8510, FVDC-8511, FVDC-8512, FVDC-8513, FVDC-8529, FVDC-8530, FVDC-8531, FVDC-8540, FVDC-8552, FVDC-8574, FVDC-8575, FVDC-8576, FVDC-8577, FVDC-8578, FVDC-8579, FVDC-8580, FVDC-8581, FVDC-8582, FVDC-8583, FVDC-8584, FVDC-8585, FVDC-8586, FVDC-8587, FVDC-8588, FVDC-8589, FVDC-8590, FVDC-8591, FVDC-8592, FVDC-8593, FVDC-8594, FVDC-8595, FVDC-8596, FVDC-8597, FVDC-8598, FVDC-8635, FVDC-8636, FVDC-8637, FVDC-8638, FVDC-8639, FVDC-8640, FVDC-8641, FVDC-8642, FVDC-8643, FVDC-8644, FVDC-8647, FVDC-8649, FVDC-8650, FVDC-8664, FVDC-8665, FVDC-8666, FVDC-8667, FVDC-8668, FVDC-8669, FVDC-8670, FVDC-8671, FVDC-8672, FVDC-8673, FVDC-8684, FVDC-8685, FVDC-8686, FVDC-8687, FVDC-8688, FVDC-8689, FVDC-8690, FVDC-8691, FVDC-8692, FVDC-8693, FVDC-8694, FVDC-8695, FVDC-8696, FVDC-8727, FVDC-8728, FVDC-8729, FVDC-8764, FVDC-8765, FVDC-8766, FVDC-8767, FVDC-8807, FVDC-8808

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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