Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The CapsoCam Plus (SV-3) Recalled by Capso Vision, Inc. Due to Ingestible video capsule system has capsule with incorrect...
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
The CapsoCam Plus (SV-3); Device Common Name: System, Imaging, Gastrointestinal, Wireless, Capsule; Catalog Number 2795 - Product Usage: 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: 82
Why Was This Recalled?
Ingestible video capsule system has capsule with incorrect capture mode which will not record data when the capsule is ingested by patients. If used, there is a risk of delay of diagnosis and the patient may need to repeat the exam.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Capso Vision, Inc.
Capso Vision, Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report