Recall Z-2722-2026 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci SP Instrument Arm Drape, SP, 1-PACK, Part Number: 430013-13, 430013-15
| Date | Jul 10, 2026 (initiated May 12, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | On 5/12/2025, correction notices were emailed to customers informing them of the following: 1) Conduct pre-use inspection steps outlined prior to each procedure, see below. 2) If you encounter a drape that does not pass the inspection steps, contact firm customer service. 3) Complete and return the acknowledgement form via email to Recalls@intusurg.com or EU.fsca@intusurg.com If you need further information or support concerning this Safety Notice, please contact your Clinical Sales Representative or contact firm Customer Service at the numbers listed below: - North and South America: (800) |
| Quantity | 11113 |
| 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, J |
| FDA record | Open on fda.gov |