8MM,LONG TIP FORCEPS,IS4000 REF 471048
FDA Recall #Z-0872-2025 — Class II — December 19, 2024
Product Description
8MM,LONG TIP FORCEPS,IS4000 REF 471048
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
1,562
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: 471048 Part Number: 471048-09 UDI-DI code: 00886874115930 Batch Numbers: K10230330 K10230420 K10230515 K10230706 K10230720 K10230810 K10230907 K10230921 K10231005 K10231019 K10231102 K10231123 K10231207 K10240229 K10240314 K10240321 K10240411 K10240418 K10240509 K10240516 K10240718 K10240725 K10240822
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated