Intuitive Surgical, Inc. recalls da Vinci SP Instrument Arm Drape

Recalling company

Intuitive Surgical, Inc.

Product

da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15

Reason

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. Retrospectively reported recall.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

May 12, 2025

Reported

Jul 22, 2026

Distribution

Worldwide - US Nationwide distribution in the states of NJ, OR, NY, FL, AL, SD, TX, VA, WV, PA, CA, WA, CT, MA, IL, OK, OH, MI, NC, MO, KY, WI, AZ, CO, GA, MD, SC, IN, NV, TN, MS, KS, IA, UT, MN, LA, NE, ME and the countries of Germany, Sweden, United Kingdom, Italy, Belgium, Switzerland, Denmark, Japan, South Korea, Hong Kong, Taiwan, France, Ireland, Spain.

Status

Ongoing

Quantity

11113

Lot / codes

UDI-DI: 00886874113486, Lot: 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, 1394LA0100

Company location

Sunnyvale, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-2722-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2722-2026 in the FDA Enforcement Report. Also see FDA recall press releases.