# FDA recall Z-2131-2020

> **Intuitive Surgical, Inc.** · Class II · device recall initiated 2019-08-19.

## Product

da Vinci SP Camera; PN 430060-33; Model Number: 430060-33.  For endoscopic surgery.

## Reason for recall

Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging; additionally if a small piece of inert epoxy were to be retained, scar tissue could form.

## Distribution

Distribution US nationwide and South Korea.

## Key facts

- **Recall number:** Z-2131-2020
- **Recalling firm:** Intuitive Surgical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-08-19
- **Report date:** 2020-06-03

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2131-2020

## Citation

> AI Analytics. FDA recall Z-2131-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2131-2020. Source: US FDA. Licensed CC0.

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