8MM,FORCE BIPOLAR,IS4000 REF 471405
FDA Device Recall #Z-0883-2025 - Class II, December 19, 2024
Recall Summary
| Recall Number | Z-0883-2025 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 19, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Intuitive Surgical, Inc. |
| Location | Sunnyvale, CA |
| Product Type | Devices |
| Quantity | 46,759 |
Product Description
8MM,FORCE BIPOLAR,IS4000 REF 471405
Reason for Recall
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Distribution Pattern
U.S. - Nation-wide. Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and Puerto Rico. O.U.S: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, French Guiana, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, and Vietnam
Lot / Code Information
Model Number: 471405 Part Number: 471405-06 UDI-DI code: 00886874120767 Batch Numbers: K10221204 K10221212 K10221218 K10230111 K10230212 K10230219 K10230226 K10230302 K10230310 K10230413 K10230420 K10230504 K10230515 K10230518 K10230525 K10230531 K10230601 K10230608 K10230615 K10230622 K10230630 K10230706 K10230713 K10230727 K10230803 K10230810 K10230817 K10230824 K10230831 K10230914 K10230928 K10231005 K10231012 K10231019 K10231027 K10231102 K10231109 K10231123 K10231130 K10231218 K10240104 K10240111 K10240118 K10240124 K10240208 K10240215 K10240219 K10240222 K10240229 K10240307 K10240327 K10240404 K10240411 K10240415 K10240418 K10240419 K10240425 K10240509 K10240516 K10240520 K10240530 K10240711 K10240728 K10240815 K10240822 K11221204 K11221212 K11221218 K11230212 K11230226 K11230302 K11230310 K11230413 K11230420 K11230515 K11230518 K11230525 K11230601 K11230608 K11230615 K11230622 K11230706 K11230713 K11230727 K11230803 K11230810 K11230914 K11231005 K11231019 K11231109 K11231116 K11240104 K11240111 K11240118 K11240208 K11240229 K11240307 K11240411 K11240418 K11240509 K11240516 K11240530 K11240711 K11240815 K11240822 K11240829 K12221204 K12221218 K12230122 K12230212 K12230226 K12230302 K12230515 K12230518 K12230525 K12230608 K12230615 K12230622 K12230706 K12230713 K12230810 K12230914 K12231109 K12240104 K12240118 K12240208 K12240229 K12240307 K12240418 K12240509 K12240530 K12240711 K12240829 K13230212 K13230226 K13230302 K13230525 K13230608 K13230706 K13230713 K13240711 K14230212 K14230226 K14230302 K14230525 K14230706 K14240711 K15230226 K15230525 K16240508 K16240530 U10230626 U10230714 U10230803 U10231201 U10231214 U10240112 U10240126 U11230803
Other Recalls from Intuitive Surgical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2310-2026 | Class II | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 ... | Apr 24, 2026 |
| Z-2521-2026 | Class II | Da Vinci ASSY, PSS, SP1098, Part Number: 380601 | Apr 22, 2026 |
| Z-2046-2026 | Class II | Brand Name: Da Vinci X and Da Vinci Xi Product... | Apr 2, 2026 |
| Z-1855-2026 | Class I | Intuitive 8 mm SureForm 30 Gray Reloads Refer... | Mar 11, 2026 |
| Z-1355-2026 | Class II | da Vinci 5 Surgeon Console Viewer Display, ASSY... | Dec 30, 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.