Home / Recalls / Intuitive Surgical, Inc. / Z-2131-2020

Z-2131-2020 Class II Ongoing

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
June 3, 2020
Initiation Date
August 19, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product 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.

Code Information

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

Other recalls by Intuitive Surgical, Inc.

  • Z-2046-2026 Class II — Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical S (April 2, 2026)
  • Z-1855-2026 Class I — Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230 (March 11, 2026)
  • Z-1355-2026 Class II — da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part Numbe (December 30, 2025)
  • Z-1096-2026 Class II — da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2. (December 15, 2025)
  • Z-1697-2026 Class II — Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: (December 9, 2025)
  • Z-1696-2026 Class II — Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: d (December 9, 2025)
  • Z-1700-2026 Class II — Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci (December 9, 2025)
  • Z-1701-2026 Class II — Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da V (December 9, 2025)
  • Z-1699-2026 Class II — Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci (December 9, 2025)
  • Z-1698-2026 Class II — Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci (December 9, 2025)