8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
FDA Recall #Z-0859-2025 — Class II — December 19, 2024
Product Description
8MM,FENESTRATED BIPOLAR FORCEPS,IS4000¿ REF 470205
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
12,340
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: 470205 Part Number: 470205-17 UDI-DI code: 00886874112359 Batch Numbers: K10221204 K10221218 K10230103 K10230219 K10230226 K10230310 K10230316 K10230323 K10230330 K10230405 K10230413 K10230420 K10230504 K10230526 K10230601 K10230615 K10230622 K10230629 K10230817 K10230824 K10230913 K10230921 K10230928 K10231019 K10231027 K10231102 K10231109 K10240129 K10240201 K10240222 K10240229 K10240307 K10240314 K10240321 K10240327 K10240404 K10240411 K10240502 K10240516 K10240523 K10240801 K11230316 K11230413 K11231116 K11240201 K11240327 K15240516
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated