The CapsoCam Plus — Class II medical device recall Z-2536-2020
Terminated recall by Capso Vision, Inc., reported 2020-07-15, distributed nationwide. Ingestible video capsule system has capsule with incorrect capture mode which will not record data when the ca
| Recall number | Z-2536-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Capso Vision, Inc., Saratoga, CA, United States |
| Recall initiated | 2020-02-26 |
| Classified | 2020-07-08 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2021-01-28 |
| Distributed | Nationwide (US) |
| Quantity | 82 |
| Lot numbers | 01-19-0070 |
| Model numbers | 2795 |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2536-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.