# FDA recall Z-1827-2020

> **Capso Vision, Inc.** · Class II · device recall initiated 2019-10-18.

## 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.

## Distribution

U.S.: CA, TX, FL, VA, PA, SC, HI, DC, NJ, UT, LA.    Foreign: FR, AR, IT, UK, BE, TC, AU, CO, GM, GR, SP, SI, HR, MO, SW, EZ.

## Key facts

- **Recall number:** Z-1827-2020
- **Recalling firm:** Capso Vision, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-18
- **Report date:** 2020-05-06
- **Termination date:** 2021-01-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saratoga, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1827-2020

## Citation

> AI Analytics. FDA recall Z-1827-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1827-2020. Source: US FDA. Licensed CC0.

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