Pentax of America Inc: Medical Device Recall in 2025 - (Recall #: Z-2329-2025)

Pentax Medical Video Processor; Model Number: EPK-i8020c;

Class II

During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient and may cause thermal injury to the patient s mucous membrane.

Model Number: EPK-i8020c; UDI-DI: 04961333247974; Serial Numbers: B0023Z1657, D0023Z0245, D0023Z0206, D0023Z0125, D0023Z0123, D0023Z0119, D0023Z0118, D0023Z0117, D0023Z0114, D0023Z0112, D0023Z0109, D0023Z0108, D0023Z0011, C0023Z0087, C0023Z0085, C0023Z0074, C0023Z0072, C0023Z0021, B0023Z1712, B0023Z1711, B0023Z1670, B0023Z1665, B0023Z1659, B0023Z1653, B0023Z1628, b0023z1501, B0023Z1195, B0023Z1707, C0023Z0084, B0023Z1732, B0023Z1669, D0023Z0137, D0023Z0141, D0158Z0049, D0158Z0033, E0023Z0022, D0158Z0053, D0158Z0019, E0023Z0026, E0023Z0008, D0023Z0248, D0023Z0241, D0023Z0222, D0023Z0155, B0023Z1276, C0023Z0082, D0023Z0233, B0023Z1461, D0023Z0139, D0023Z0140, D0023Z0122, B0023Z1709, E0023Z0020, E0023Z0009, E0023Z0002, D0023Z0142, E0023Z0024, E0023Z0018, E0023Z0013, E0023Z0004, C0023Z0095, C0023Z0078, E0023Z0007, E0158Z0057, E0158Z0035, B0023Z1735, B0023Z1717, B0023Z1648, B0023Z1639, B0023Z1631, C0158Z0047, C0158Z0042, B0023Z1481, B0023Z1478, B0023Z1451, B0023Z1335, B0023Z1193, B0023Z1288, B0023Z1258, B0023Z1296, B0023Z1290, B0023Z1286, B0023Z1280, B0023Z1279, B0023Z1256, B0023Z1250, B0023Z1245, B0023Z1676, B0023Z1573, B0023Z1565, B0023Z1656, B0023Z1694, D0158Z0055, B0023Z1577, B0023Z1570, B0023Z1682, B0023Z1678, B0023Z1661, B0023Z1637, D0158Z0048, D0158Z0047, E0023Z0016, E0023Z0001, D0023Z0071, D0023Z0150, D0023Z0148, D0023Z0143, B0023Z1277, D0023Z0152, D0023Z0144, D0023Z0106, D0023Z0102, B0023Z1667, B0023Z1652, B0023Z1645, B0023Z1727, B0023Z1723, B0023Z1702, E0023Z0003, D0023Z0244, D0023Z0232, C0023Z0091, D0023Z0208, B0023Z1655, D0023Z0219, D0023Z0017, D0023Z0008, C0023Z0098, C0023Z0097, C0023Z0096, C0023Z0094, C0023Z0092, B0023Z1716, B0023Z1698, B0023Z1697, B0023Z1696, B0023Z1671, B0023Z1255, B0023Z1247, B0023Z1291, B0023Z1289, B0023Z1287, B0023Z1285, B0023Z1243;

US Distribution to states of: AZ, CA, DC, FL IA, ID, IL, KS, MA, MD, MI, MO, NC, NJ, NM, NY, OK, PA, TX, WA.

Voluntary: Firm initiated