Pentax Ultrasound Video Gastroscope Recalled for Incorrect Disinfection Instructions
Pentax of America Inc. is recalling 118 ultrasound video gastroscopes because the instructions for use contain an error in the disinfection step.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a documentation error (incorrect instructions) rather than a direct physical defect or reported injury, fitting the 'Moderate' criteria for minor labeling/documentation issues.
Plain-English summary
Pentax of America Inc. is recalling 118 units of the Ultrasound Video Gastroscope, Model EG-3670URK. The product is intended to be used in combination with an ultrasound scanning unit made by Hitachi Medical Corporation and a PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract. The recall is nationwide.
The recall is due to an error in the reprocessing instructions found in Revisions 13 and 14 of the Instructions for Use (IFU) Z845. The IFU incorrectly states that the cleaning detergent solution should remain in contact with the internal channels and external endoscope surfaces during the disinfection step. The instructions should specify that the disinfecting solution, not the cleaning detergent, is used for this step. This error also affects the EG-3870UTK model.
No specific actions for consumers are provided in the source text, but the recall is initiated by Pentax of America Inc. to address the documentation error.
The recalled product
- Product
- Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy…
- Manufacturer
- Pentax of America Inc
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 118
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 (20)
- Serial Numbers: G110307
- H110482
- H110484
- H110487
- H110489
- G110334
- G110338
- G110404
- G110296
- G110358
- G110340
- G110341
- G110407
- G110409
- H110432
- G110345
- H110450
- G110391
- H110476
- H110443
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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.
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