FDAClass IIFebruary 26, 2020

Pentax Video Colonoscope recall

Pentax Video Colonoscope Model: EC38-i10L

Why was Pentax Video Colonoscope recalled?

Distributed in the USA without an approved 510K

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial Numbers:L110746

Product
Pentax Video Colonoscope Model: EC38-i10L
Recalling firm
Pentax of America Inc
Quantity
1 unit
Distribution
NC, MA
Recall date
February 26, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls