Summary
The FDA issued a Class II for Pentax Medical Video Processor; Model Number: EPK-i8020c; by Pentax of America Inc. Reason: During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become redd.
Details
Source
Device Recall
External ID
Z-2329-2025
Action Date
2025-08-27
Status
Ongoing
Category
device
Product Description
Pentax Medical Video Processor; Model Number: EPK-i8020c;
Lot/Code Info: 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;
Quantity Affected: 144 units
Reason for Recall
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-16
Company
Montvale, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 135 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Pentax of America Inc has 22 FDA actions in our database, including 6 recalls and 16 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Pentax of America Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pentax of America Inc have FDA actions?
Pentax of America Inc has 22 FDA actions in our database, including 6 recalls and 16 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2329-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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