Z-2329-2025Class II

Pentax Medical Video Processor; Model Number: EPK-i8020c

Name: Z-2329-2025 Pentax Medical Video Processor; Model Number: EPK-i8020c
Creator: Pentax of America Inc
Published: 2025-07-16
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2025-07-16 / Open, Classified / root cause: design

FDA source

Pentax of America Inc began a recall of Pentax Medical Video Processor; Model Number: EPK-i8020c on 2025-07-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2329-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-16
Posted: 2025-08-15
Recalling firm: PENTAX of America, Inc.
Product: Pentax Medical Video Processor; Model Number: EPK-i8020c;
Product code: PEA Endoscope, Accessories, Image Post-Processing For Color Enhancement
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.
Root cause tag: design
FDA root cause: Device Design
Action: On 7/16/2025, "URGENT MEDICAL DEVICE CORRECTION" letters were sent to customers. Customer Instructions: PENTAX Medical will conduct the software update on the affected devices at your facility. Your local PENTAX Medical representative will contact you to schedule the required updates for your equipment. " Please download the Instructions for Use (IFU) for the EPK-i8020c Video Processor from the PENTAX Medical online IFU library at https://ifu.pentaxmedical.com. " Please complete the enclosed Field Correction Response Form upon receipt of this package, and email to PENTAX Medical at [email protected]. Contact Information: Please indicate through the attached response form that you have received and understood this information, by completing it and returning it no later than July18, 2025 at: [email protected] If you have any questions regarding this action, please feel free to contact us at: " Tel: 1-800-431-5880 (8:30 AM 5:00 PM, Monday Friday, EST) " Fax: (800)-579-5432) " Email: [email protected]
Quantity in commerce: 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.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2329-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2329-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-27	2025-08-15

Product code PEA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)