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RecallWatchMedical Device Safety
Class IIOngoingZ-2521-2026

Intuitive Surgical, Inc. recalls Da Vinci ASSY

Intuitive Surgical, Inc.Sunnyvale, CA, United StatesReported Jul 1, 2026 · 17 days ago
Legal News Analyst ·

Reason for recall

Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Da Vinci ASSY, PSS, SP1098, Part Number:380601
    UDI 00886874114605.
    400 affected lots
    605408606848612328628399609353614073617794616769
    +392 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

What the firm is doing

On 4/22/2026, correction notices were mailed and emailed to customers who were asked to do the following: 1. This notice needs to be passed on to all those who need to be aware within your organization or functions where the potentially affected devices have been transferred. 2. Please retain a copy of this letter, place a copy with your affected system, and keep a copy of the acknowledgement form for your files. 3. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. A firm Representative will schedule a site visit to perform an inspection of the system. If you need further information or support concerning this Medical Device Correction, please contact your da Vinci SP Sales Representative or contact Intuitive Customer Service at the numbers listed below: " North and South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: customerservice@intusurg.com. " Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or eucs@intusurg.com " South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or support.korea@intusurg.com " Japan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) or csjapan@intusurg.com " India: +1-800-103-6952 (9 am to 6 pm IT) " Taiwan: +0800-86-8181 (9 am to 6 pm CT)

DistributionShow details

Worldwide - US Nationwide distribution including in the states of CA, GA, OH, PA, NY, MN, TN, OR, IL, MD, NJ, AL, NV, TX, FL, LA, CT, NC, AZ, IA, MO, WA, MI, WV, WI, KY, KS, VA, OK, MA, IN, CO, SC, SD, MS, NH, UT, ME and the countries of Belgium, Denmark, Sweden, France, Japan, Germany, Israel, Switzerland, South Korea, Czech Republic, Austria, United Kingdom, Italy, Spain, Ireland, Saudi Arabia, Greece, Taiwan, Australia, China, Turkey, Poland, United Arab Emirates, Hong Kong, Romania.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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