FDA Medical devices recall ·
8MM,FORCE BIPOLAR,IS4000 recall
- Recall number
- Z-0883-2025
- Date
- (initiated December 19, 2024)
- Company / brand
- Intuitive Surgical, Inc.
1266 Kifer Rd, Sunnyvale, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 46,759
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
8MM,FORCE BIPOLAR,IS4000 REF 471405
Why was it recalled?
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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 K14
Distribution
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
States: Alaska Alabama Arkansas Arizona California Colorado Connecticut District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina North Dakota Nebraska New Hampshire New Jersey New Mexico Nevada New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Utah Virginia Vermont Washington Wisconsin West Virginia Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0883-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.