Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

CapsoCam Plus *** System Recalled by Capso Vision, Inc. Due to Possible mis-labeling of the device with incorrect serial...

Date: July 3, 2019
Company: Capso Vision, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Capso Vision, Inc. directly.

Affected Products

CapsoCam Plus *** System, Imaging, Gastrointestinal, Wireless, Capsule, Electrical Rating 3.1V DC/10mA REF 2795 - Product Usage: The CapsoCam Plus video capsule system is intended for visualization of the small bowel mucosa in adults. It may be used as a tool in the detection of abnormalities of the small bowel.

Quantity: 44 units

Why Was This Recalled?

Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Capso Vision, Inc.

Capso Vision, Inc. has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report