Agency classClass IIOur severity:High FDA (Devices)·Z-1238-2025·Announced 2025-03-05

Pentax EPK-i8020c Video Processor Recalled for Thermal Burn Risk

Pentax EPK-i8020c video processors can overheat during endoscopic procedures, creating a risk of thermal burns to patient tissues. The light guide tip becomes hot and may cause injury to mucous membranes.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall affecting medical devices used in patient procedures. The device poses a theoretical risk of thermal burn to patient mucous membranes, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported,' with no illnesses or injuries documented.

Plain-English summary

The recalled product is the Pentax Medical Video Processor Model EPK-i8020c, a Class II medical device used with PENTAX Medical endoscopes and peripheral devices for endoscopic diagnosis and treatment. This recall affects 94 units distributed nationwide and can be identified by specific serial numbers.

During endoscopic procedures using the EPK-i8020c with i20c series video endoscopes, the light guide at the tip can become excessively hot, creating a risk of thermal injury to the patient's mucous membranes. Users have observed smoke-like steam during use and after removal of the endoscope from the patient. Additionally, the displayed image can become reddish or dark in some cases, occurring in approximately 1.8% of observed uses.

Healthcare facilities should identify whether they possess any affected units using the provided serial numbers. The thermal injury hazard poses a risk to patients undergoing endoscopic procedures. Although no patient injuries have been reported, the recall requires that affected units be managed appropriately to prevent patient harm.

The recalled product

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
Manufacturer: Pentax of America Inc
Category: Medical Device — Endoscopic Equipment
Hazard: burn-injury
Affected units: 94

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Pentax of America Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Pentax of America Inc

See all →

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Same hazard · burn injury