Official recall record
Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic dia
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-01-29
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 04961333247974
- Brand on record
- Pentax of America Inc
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2025-07-16 · US FDA — Medical Devices
Pentax Medical Video Processor; Model Number: EPK-i8020c;
Other recalls from this brand
- 2025-07-16 · US FDA — Medical Devices
Pentax Medical Video Processor; Model Number: EPK-i8020c; - 2025-01-29 · US FDA — Medical Devices
PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and th