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

FDA Device Recall #Z-2131-2020 — Class II — August 19, 2019

Recall Summary

Recall Number Z-2131-2020
Classification Class II — Moderate risk
Date Initiated August 19, 2019
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Intuitive Surgical, Inc.
Location Sunnyvale, CA
Product Type Devices
Quantity 305 units

Product Description

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 Pattern

Distribution US nationwide and South Korea.

Lot / Code Information

Model Number: 430060-33; UDI Number: 00886874114384; All serial numbers.

Other Recalls from Intuitive Surgical, Inc.

Recall # Classification Product Date
Z-1355-2026 Class II da Vinci 5 Surgeon Console Viewer Display, ASSY... Dec 30, 2025
Z-1096-2026 Class II da Vinci SP, SP Access Port Kit, Large Incisio... Dec 15, 2025
Z-1134-2026 Class II Brand Name: Ion Endoluminal System Product Nam... Dec 4, 2025
Z-1428-2026 Class II Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/... Nov 17, 2025
Z-1232-2026 Class II Brand Name: Da Vinci Product Name: da Vinci X,... Nov 7, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.