8MM,CADIERE FORCEPS,IS4000 REF 471049
FDA Recall #Z-0873-2025 — Class II — December 19, 2024
Product Description
8MM,CADIERE FORCEPS,IS4000 REF 471049
Reason for Recall
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Recalling Firm
Intuitive Surgical, Inc. — Sunnyvale, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
56,580
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
Code Information
Model Number: 471049 Part Number: 471049-08 UDI-DI code: 00886874119778 Batch Numbers: K10221218 K10230112 K10230122 K10230219 K10230226 K10230302 K10230323 K10230405 K10230413 K10230420 K10230427 K10230515 K10230518 K10230525 K10230608 K10230615 K10230622 K10230706 K10230713 K10230714 K10230720 K10230727 K10230803 K10230817 K10230921 K10230928 K10231005 K10231012 K10231027 K10231109 K10231130 K10231205 K10231207 K10231214 K10231218 K10240104 K10240110 K10240111 K10240116 K10240118 K10240208 K10240215 K10240222 K10240308 K10240321 K10240327 K10240404 K10240411 K10240418 K10240509 K10240516 K10240530 K10240606 K10240613 K10240614 K10240620 K10240621 K10240711 K10240718 K10240725 K10240903 K11230112 K11230226 K11230405 K11230515 K11230518 K11230525 K11230608 K11230615 K11230622 K11230706 K11230713 K11230714 K11230720 K11230727 K11230803 K11230817 K11230921 K11230928 K11231012 K11231027 K11231109 K11231130 K11231207 K11231214 K11240104 K11240118 K11240208 K11240215 K11240321 K11240327 K11240404 K11240411 K11240418 K11240509 K11240516 K11240530 K11240606 K11240613 K11240620 K11240621 K11240718 K11240725 K12230112 K12230226 K12230515 K12230602 K12230608 K12230615 K12230706 K12230720 K12230727 K12230928 K12231012 K12231130 K12231214 K12240118 K12240215 K12240321 K12240418 K12240718 K13230112 K13230928 K13231012 K13231130 K13231214 K14230112 K14231130 K15230112 K16240508 K17240508 K17240830 K18240830
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated