Device Recall AxioBionics Wearable Therapy BioSleeve

Catalog numbers for BioSleeve include 10200 and 10201 and Serial numbers 1466-1469, 1472, 1380, 1425, 1371-1374, 1389, 1391, 1392, 1453, 1454, 1460, 1393, 1402, 1403, 1430, 1482, 1396, 1502, 1503, 1431, 1432, 1449, 1435, 1387, 1504, 1409, 1410, 1539 and 1540. Catalog numbers for the BioGel Velcro Electrodes include118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, and 130.

Neurological Devices

2

No

Nationwide Distribution--USA (nationwide) including the states of AZ, GA, IL, IN, MI, MO, NY, TX, and WY.

AxioBionics Wearable Therapy Upper Extremity BioSleeve (Right and Left) that includes 2-16 BioGel Velcro Electrodes in sizes: 2"x2", 2"x2.5", 2"x3", 2"x3.5", 2"x4", 2"x5", 2"x6", 2"x8", 1.5"x3", 1.5"x5", 1.5"x6", and 1"x1.5". || Cutaneous electrode garments for neuromuscular electrical stimulation.