Pentax Video Duodenoscope Recall for Surface Soiling Investigation
Pentax of America Inc. issued a field correction for two Video Duodenoscope models to investigate surface soiling on the suction cylinder and distal cap.
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: The recall involves a high-risk medical device (duodenoscope) with a potential contamination hazard (soiling) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Pentax of America Inc. has initiated a field correction and safety alert for two models of the Video Duodenoscope, specifically the ED-3490TK and ED-3270K. These medical instruments are designed to provide optical visualization and therapeutic access to the biliary tract via the upper gastrointestinal tract.
The recall was initiated to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing. The source text does not specify if any patient injuries or illnesses have been reported as a result of this soiling.
The affected units were distributed worldwide, including nationwide distribution in the United States and in Canada. A total of 2,015 units are involved in this field correction, with 519 units of the ED-3490TK model and 5 units of the ED-3270K model in the US, and 1,491 units outside the US.
The recalled product
- Product
- Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus…
- Manufacturer
- Pentax of America Inc
- Category
- Medical Device — Endoscopy
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Numbers: Ed-3490TK and ED-3270K
Distribution
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