da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip...

FDA Device Recall #Z-0999-2022 — Class II — March 17, 2022

Recall Summary

Recall Number Z-0999-2022
Classification Class II — Moderate risk
Date Initiated March 17, 2022
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Intuitive Surgical, Inc.
Location Sunnyvale, CA
Product Type Devices
Quantity 6,8881 boxes (or 413,286 individual units/6 instruments/box)

Product Description

da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60 REF 480460

Reason for Recall

As a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed distally within the jaws, rather than being held in place and transected. Overall rate of harm associated with bleeding of critical severity exceeds the predicted likelihood of harm as documented within Intuitives existing risk documentation.

Distribution Pattern

Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY. The countries of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Monaco, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

Lot / Code Information

Product Description/Model Numbers/UDI Code: Sureform 45 / 480445 / 00886874117583 Sureform 45 Curved-Tip / 480545 / 00886874117590 Sureform 60 / 480460 / 00886874115640 All Lots

Other Recalls from Intuitive Surgical, Inc.

Recall # Classification Product Date
Z-1355-2026 Class II da Vinci 5 Surgeon Console Viewer Display, ASSY... Dec 30, 2025
Z-1096-2026 Class II da Vinci SP, SP Access Port Kit, Large Incisio... Dec 15, 2025
Z-1134-2026 Class II Brand Name: Ion Endoluminal System Product Nam... Dec 4, 2025
Z-1428-2026 Class II Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/... Nov 17, 2025
Z-1232-2026 Class II Brand Name: Da Vinci Product Name: da Vinci X,... Nov 7, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.