Pentax Medical Video Processor recall
Pentax Medical Video Processor; Model Number: EPK-i8020c;
Why was Pentax Medical Video Processor recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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;
- Product
- Pentax Medical Video Processor; Model Number: EPK-i8020c;
- Recalling firm
- Pentax of America Inc
- Quantity
- 144 units
- Distribution
- 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.
- Recall date
- August 27, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)