How many FDA warning letters has Intuitive Surgical, Inc. received?

Argus HQ has not recorded an FDA warning letter for Intuitive Surgical, Inc. in our current dataset.

What FDA recalls has Intuitive Surgical, Inc. issued?

Argus HQ has recorded 4 FDA recalls tied to Intuitive Surgical, Inc..

Is Intuitive Surgical, Inc. FDA compliant?

Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 4 recalls, and 0 approval records for Intuitive Surgical, Inc.. Review the linked FDA source records directly before drawing a compliance conclusion.

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company

Intuitive Surgical, Inc.

Name: FDA Enforcement Actions Against Intuitive Surgical, Inc.
Creator: Argus HQ
License: https://argushq.ai/methodology

Jurisdiction: US

FDA Warning Letter timeline

V1 scope: FDA Warning Letters only. Additional public-record sources (SEC, CPSC, federal contracts) are on the V2 roadmap and are not surfaced here today.

fda_recall · device_recall2026-07-01
Intuitive Surgical, Inc. — Class II recall: Da Vinci ASSY, PSS, SP1098, Part Number: 380601
fda_recall · device_recall2026-06-10
Intuitive Surgical, Inc. — Class II recall: Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Numbe…
fda_recall · device_recall2026-05-13
Intuitive Surgical, Inc. — Class I recall: Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230…
fda_recall · device_recall2026-05-13
Intuitive Surgical, Inc. — Class II recall: Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical S…

Frequently asked questions

How many FDA warning letters has Intuitive Surgical, Inc. received?: Argus HQ has not recorded an FDA warning letter for Intuitive Surgical, Inc. in our current dataset.
What FDA recalls has Intuitive Surgical, Inc. issued?: Argus HQ has recorded 4 FDA recalls tied to Intuitive Surgical, Inc..
Is Intuitive Surgical, Inc. FDA compliant?: Argus HQ is not a compliance rating service. As of this page's last update, our dataset shows 0 warning letters, 4 recalls, and 0 approval records for Intuitive Surgical, Inc.. Review the linked FDA source records directly before drawing a compliance conclusion.

Informational only. FDA Warning Letters are public records (17 USC §105). Summaries are AI-assisted and may contain errors; always verify against the original FDA letter before acting. Not legal, financial, or regulatory advice.