# FDA recall Z-2536-2020

> **Capso Vision, Inc.** · Class II · device recall initiated 2020-02-26.

## 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.

## Distribution

US Nationwide distribution including in the states of AZ, CA, DE, MD, NJ, NY, SC, and VA.

## Key facts

- **Recall number:** Z-2536-2020
- **Recalling firm:** Capso Vision, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-02-26
- **Report date:** 2020-07-15
- **Termination date:** 2021-01-28

- **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-2536-2020

## Citation

> AI Analytics. FDA recall Z-2536-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2536-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*