Pentax Video Colonoscope Recalled for Lack of FDA Approval
Pentax of America Inc is recalling one unit of the EC38-i10L Video Colonoscope because it was distributed in the USA without an approved 510(k).
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 corresponds to a moderate severity score. The hazard is a regulatory compliance issue (lack of 510(k) approval) rather than a direct physical defect causing injury.
Plain-English summary
Pentax of America Inc is recalling one unit of the Pentax Video Colonoscope, Model EC38-i10L. The recall is being conducted because the device was distributed in the United States without an approved 510(k) clearance from the FDA.
The affected unit has the serial number L110746. The device was distributed in North Carolina and Massachusetts.
Consumers and healthcare providers who possess this specific unit should stop using it and contact Pentax of America Inc for further instructions.
The recalled product
- Product
- Pentax Video Colonoscope Model: EC38-i10L
- Manufacturer
- Pentax of America Inc
- Category
- Medical Device — Endoscopy
- Affected units
- 1
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)
- Serial Numbers:L110746
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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