Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CapsoCAM Plus Recalled by Capso Vision, Inc. Due to Capsule Endoscopy System: a defect present in the...
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, UDI: 00867770000209
Quantity: 1882
Why Was This Recalled?
Capsule Endoscopy System: a defect present in the capsule window may be stressed through the production process and in the final package, which could cause the housing of the capsule to crack and leak when ingested. Fluid from the patient could leak in to the capsule, which may damage components inside the capsule and the patient data may not be retrieved; the patient may need to repeat the exam.
Where Was This Sold?
This product was distributed to 14 states: AR, CA, CO, FL, HI, LA, MO, NJ, PA, SC, TX, UT, VA, DC
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