8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
FDA Recall #Z-0852-2025 — Class II — December 19, 2024
Product Description
8MM,DEBAKEY FORCEPS,IS4000 ¿ REF 470036
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
1,739
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: 470036 Part Number: 470036-04 UDI-DI code: 00886874112236 Batch Numbers: K10221128 K10221218 K10230219 K10230226 K10230323 K10230518 K10230525 K10230601 K10230608 K10230615 K10230713 K10230824 K10230907 K10231005 K10231019 K10231214 K10240208 K10240222 K10240411 K10240418 K10240711 K10240722 K10240801 Part Number: 470036-06 UDI-DI code: 00886874112229 Batch Number: K10230803
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated