CapsoCam Plus *** System — Class II medical device recall Z-2073-2020
Terminated recall by Capso Vision, Inc., reported 2020-05-27, distributed nationwide. Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdia
| Recall number | Z-2073-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Capso Vision, Inc., Saratoga, CA, United States |
| Recall initiated | 2019-07-03 |
| Classified | 2020-05-21 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2021-01-28 |
| Distributed | Nationwide (US) |
| Quantity | 44 units |
| Reason classes | labeling |
| Lot numbers | 02-18-0036 |
| Model numbers | 2795 |
Product
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.
Reason for recall
Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.
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-2073-2020. 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.