Recall archive / FDA device enforcement
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral dev... — FDA record Z-1238-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 29, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c
- Reason
- During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or dark (1.8%). 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 membranes.
- Classification
- Class II
- Recalling firm
- Pentax of America Inc
- Quantity
- 94 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1238-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI: 04961333247974 Serial Numbers: B0023Z1193 B0023Z1195 B0023Z1245 B0023Z1247 B0023Z1250 B0023Z1255 B0023Z1256 B0023Z1276 B0023Z1277 B0023Z1279 B0023Z1280 B0023Z1286 B0023Z1290 B0023Z1296 B0023Z1313 B0023Z1335 B0023Z1451 B0023Z1461 B0023Z1478 B0023Z1481 B0023Z1565 B0023Z1573 B0023Z1628 B0023Z1631 B0023Z1637 B0023Z1639 B0023Z1645 B0023Z1648 B0023Z1652 B0023Z1653 B0023Z1655 B0023Z1656 B0023Z1659 B0023Z1661 B0023Z1665 B0023Z1667 B0023Z1669 B0023Z1671 B0023Z1676 B0023Z1678 B0023Z1682 B0023Z1694 B0023Z1696 B0023Z1698 B0023Z1711 B0023Z1712 B0023Z1716 B0023Z1717 B0023Z1732 C0023Z0021 C0023Z0072 C0023Z0074 C0023Z0078 C0023Z0082 C0023Z0084 C0023Z0085 C0023Z0087 C0023Z0091 C0023Z0092 C0023Z0094 C0023Z0095 C0023Z0096 C0023Z0097 D0023Z0011 D0023Z0017 D0023Z0108 D0023Z0109 D0023Z0112 D0023Z0117 D0023Z0118 D0023Z0119 D0023Z0122 D0023Z0123 D0023Z0125 D0023Z0140 D0023Z0142 D0023Z0222 D0023Z0241 D0023Z0248 D0158Z0019 D0158Z0033 D0158Z0049 D0158Z0053 E0023Z0002 E0023Z0004 E0023Z0007 E0023Z0008 E0023Z0009 E0023Z0013 E0023Z0016 E0023Z0018 E0023Z0020 E0023Z0024 E0023Z0026 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Mar 5, 2025
- Recall initiation date
- Jan 29, 2025
- Center classification date
- Feb 26, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.