Pentax Video Colonoscope Recalled for Lack of FDA Approval
Pentax of America Inc is recalling specific Pentax Video Colonoscopes because they were distributed in the USA without an approved 510K.
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, which typically corresponds to a moderate severity level when no specific injuries or illnesses are reported in the source text.
Plain-English summary
Pentax of America Inc is recalling the Pentax Video Colonoscope, Model EC34-i10L. The recall involves specific units identified by serial numbers L110300, L110301, L110303, and L110306.
The reason for the recall is that these devices were distributed in the USA without an approved 510K. The distribution pattern indicates the devices were available in North Carolina and Massachusetts.
Healthcare facilities and consumers who possess these specific serial numbers should stop using the devices and contact the recalling firm for instructions on how to proceed.
The recalled product
- Product
- Pentax Video Colonoscope Model: EC34-i10L
- 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 (4)
- Serial Numbers: L110300
- L110301
- L110303
- L110306
Distribution
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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