FDAClass IIApril 22, 2020

Endocuff Vision recall

Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to…

Why was Endocuff Vision recalled?

Updated Instructions For Use- to contraindications and potential complications/adverse events of the colonoscopy procedure (without using Endocuff Vision Device)

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?

All batches distributed prior to 1st May 2020.

Product
Endocuff Vision: models ARV 110, 120, 130, 140 Intended Use: ENDOCUFF VISION is a device attached to the distal end of a colonoscope, designed to…
Recalling firm
Boddingtons Plastics Ltd
Quantity
13202 Units US
Distribution
Nationwide Foreign:
Recall date
April 22, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
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