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 2026-07-01; 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: Da Vinci ASSY, PSS, SP1098, Part Number: 380601

Name: FDA Recall Record — Intuitive Surgical, Inc.
Creator: Argus HQ
Published: 2026-07-01
License: https://argushq.ai/methodology

Event date: 2026-07-01 00:00:00Z
Observed: 2026-07-09 22:51:53Z
Source ID: Z-2521-2026
Payload hash: 4b06c4fa833c6d4779902f97…

Summary

Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of m… 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 2026-07-01; 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: Da Vinci ASSY, PSS, SP1098, Part Number: 380601. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-intuitive-surgical-inc-z-2521-2026

MLA

"Intuitive Surgical, Inc. — Class II recall: Da Vinci ASSY, PSS, SP1098, Part Number: 380601." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-intuitive-surgical-inc-z-2521-2026.

Chicago

Argus HQ Research. "Intuitive Surgical, Inc. — Class II recall: Da Vinci ASSY, PSS, SP1098, Part Number: 380601." Digital Empire Holdings LLC. Accessed August 27, 2026. https://argushq.ai/events/fda-recall-intuitive-surgical-inc-z-2521-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_intuitive_surgical_inc_z_2521_2026_2026,
  title = {Intuitive Surgical, Inc. — Class II recall: Da Vinci ASSY, PSS, SP1098, Part Number: 380601},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-intuitive-surgical-inc-z-2521-2026},
  note = {Accessed: August 27, 2026}
}

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