Has Intuitive Surgical, Inc. had other FDA enforcement actions?

Yes. Argus HQ has recorded 5 total FDA actions tied to Intuitive Surgical, Inc.: 0 warning letters, 5 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-06-10; Argus observed and indexed it on 2026-07-09.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · high

Intuitive Surgical, Inc. — Class II recall: Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Numbe…

Name: FDA Recall Record — Intuitive Surgical, Inc.
Creator: Argus HQ
Published: 2026-06-10
License: https://argushq.ai/methodology

Event date: 2026-06-10 00:00:00Z
Observed: 2026-07-09 22:52:18Z
Source ID: Z-2310-2026
Payload hash: d43e49dff060ad28be1bd076…

Summary

Due to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions, particularly when switching from the handheld camera to the robotic endoscope. Status: Ongoing.

Entities

Intuitive Surgical, Inc.

View source record ↗

Frequently asked questions

Has Intuitive Surgical, Inc. had other FDA enforcement actions?: Yes. Argus HQ has recorded 5 total FDA actions tied to Intuitive Surgical, Inc.: 0 warning letters, 5 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-06-10; Argus observed and indexed it on 2026-07-09.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Intuitive Surgical, Inc. — Class II recall: Brand Name: Da Vinci 5  Product Name: ASSY,DV5 TOWER,IS5000  Model/Catalog Numbe…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-intuitive-surgical-inc-z-2310-2026

MLA

"Intuitive Surgical, Inc. — Class II recall: Brand Name: Da Vinci 5  Product Name: ASSY,DV5 TOWER,IS5000  Model/Catalog Numbe…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-intuitive-surgical-inc-z-2310-2026.

Chicago

Argus HQ Research. "Intuitive Surgical, Inc. — Class II recall: Brand Name: Da Vinci 5  Product Name: ASSY,DV5 TOWER,IS5000  Model/Catalog Numbe…." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/events/fda-recall-intuitive-surgical-inc-z-2310-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_intuitive_surgical_inc_z_2310_2026_2026,
  title = {Intuitive Surgical, Inc. — Class II recall: Brand Name: Da Vinci 5  Product Name: ASSY,DV5 TOWER,IS5000  Model/Catalog Numbe…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-intuitive-surgical-inc-z-2310-2026},
  note = {Accessed: August 27, 2026}
}

Informational only. Not legal, financial, or medical advice.