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fda_recall · device_recall · high

Intuitive Surgical, Inc. — Class II recall: da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15

Event date
2026-07-22 00:00:00Z
Observed
2026-07-28 04:20:59Z
Source ID
Z-2722-2026
Payload hash
30ebde1c62ac4fcba71f58dc…

Summary

Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Ret… Status: Ongoing.

Entities

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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 2026-07-22; Argus observed and indexed it on 2026-07-28.
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 SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-intuitive-surgical-inc-z-2722-2026
MLA
"Intuitive Surgical, Inc. — Class II recall: da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-intuitive-surgical-inc-z-2722-2026.
Chicago
Argus HQ Research. "Intuitive Surgical, Inc. — Class II recall: da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15." Digital Empire Holdings LLC. Accessed July 28, 2026. https://argushq.ai/events/fda-recall-intuitive-surgical-inc-z-2722-2026.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_intuitive_surgical_inc_z_2722_2026_2026,
  title = {Intuitive Surgical, Inc. — Class II recall: da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-intuitive-surgical-inc-z-2722-2026},
  note = {Accessed: July 28, 2026}
}

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

Intuitive Surgical, Inc. — Class II recall: da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15 · Argus HQ