The Recall Desk
ModerateFDA (Devices)·Z-2722-2026·Announced 2026-07-22

da Vinci SP Instrument Arm Drape may detach during surgical procedures

Intuitive Surgical is recalling da Vinci SP Instrument Arm Drapes because the drape rings may detach, exposing the instrument arm and potentially delaying procedures. The recall affects 11,113 units distributed worldwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is functional failure that may delay procedures but does not create direct patient harm risk, placing it in the Moderate category per the rubric.

Plain-English summary

Intuitive Surgical, Inc. is recalling da Vinci SP Instrument Arm Drapes (Part Numbers 430013-13 and 430013-15) due to a defect in the drape rings located at the top of the product. The rings may detach from the instrument arm during use, which can expose a section of the instrument arm.

If the drape detaches, it may result in procedure delay or conversion to an alternate minimally invasive approach. The affected product was distributed worldwide, including to facilities in the United States and internationally in Germany, Sweden, United Kingdom, Italy, Belgium, Switzerland, Denmark, Japan, South Korea, Hong Kong, Taiwan, France, Ireland, Spain, and other countries.

Affected lot numbers include 3074LA0500, 1124LA0200, 2124LA0400, 1134LA0700, 1144LA0500, 7154LA0200, 6164LA0800, 1084LA0300, 3164LAA800, 4084LA0500, 4124LA0600, 1274LA0500, 2294LA0200, 1274LA0400, 4284LA0800, 6324LA0200, 1324LA0300, 4154LA0400, 2284LA0100, 4144LA1300, 3324LA0500, 2354LA0500, 7144LA0500, 4294LA0700, 3374LA0400, 5264LA0700, 3224LA0500, 3424LA0200, and 1394LA0100. Customers who have received this product should contact Intuitive Surgical for instructions regarding the defective drapes.

The recalled product

Product
da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
Manufacturer
Intuitive Surgical, Inc.
Category
Medical Device — Surgical Equipment / Robotic-Assisted Surgery
Hazard
Affected units
11,113

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • UDI-DI: 00886874113486
  • Lot: 3074LA0500
  • 1124LA0200
  • 2124LA0400
  • 1134LA0700
  • 1144LA0500
  • 7154LA0200
  • 6164LA0800
  • 1084LA0300
  • 3164LAA800
  • 4084LA0500
  • 4124LA0600
  • 1274LA0500
  • 2294LA0200
  • 1274LA0400
  • 4284LA0800
  • 6324LA0200
  • 1324LA0300
  • 4154LA0400
  • 2284LA0100

Distribution

Distributed nationwide across the United States.

The notice also names 38 states specifically:

Related recalls

Same manufacturer · Intuitive Surgical, Inc.

See all →

Same hazard · product detachment

See all →