CapsoCAM Plus — Class II medical device recall Z-1827-2020
Terminated recall by Capso Vision, Inc., reported 2020-05-06, distributed in AR, CA, DC, FL, HI, LA, NJ, PA…. Capsule Endoscopy System: a defect present in the capsule window may be stressed through the production proces
| Recall number | Z-1827-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Capso Vision, Inc., Saratoga, CA, United States |
| Recall initiated | 2019-10-18 |
| Classified | 2020-04-30 |
| Reported by FDA | 2020-05-06 |
| Terminated | 2021-01-08 |
| Distributed | AR, CA, DC, FL, HI, LA, NJ, PA, SC, TX, UT, VA |
| Countries outside the US | GB |
| Quantity | 1,882 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00867770000209 |
| Serial numbers | A00Y8H.687, A00Z1S.699, A00Z32.699, A00Z43.699, A00Z4G.699, A00Z4X.699, A00Z5G.699, A00Z5N.699, A00Z6H.699, A00Z6M.699, A00Z6N.699, A00Z6R.699, A00Z7B.699, A00Z7E.699, A00Z81.699, A00Z8C.699, A00Z8E.699, A00Z9T.699, A00ZB7.699, A00ZH8.699, A00ZK9.699, A00ZM1.699, A00ZS6.699, A00ZV6.699, A0100G.699 and 475 more |
Product
CapsoCAM Plus, UDI: 00867770000209
Reason for recall
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.
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-1827-2020. 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.