Home / Recalls / Intuitive Surgical, Inc. / Z-0866-2025

Z-0866-2025 Class II Ongoing

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

FDA device recall Z-0866-2025 was initiated by Intuitive Surgical, Inc. on Dec 19, 2024 and is designated Class II. Reason for recall: Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. The recall status is ongoing. Affected quantity: 9,303.

Recall Details

Product Type: Devices
Report Date: Jan 22, 2025
Initiation Date: Dec 19, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9,303

Product Description

8MM,SMALL GRASPING RETRACTOR,IS4000¿ REF 470318

Reason for Recall

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

Distribution Pattern

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: 470318 Part Number: 470318-10 UDI-DI code: 00886874112441 Batch Numbers: K10230212 K10230219 K10230226 K10230420 K10230504 K10230511 K10230518 K10230525 K10230601 K10230608 K10230615 K10230706 K10230713 K10230803 K10230817 K10230831 K10230914 K10230921 K10230928 K10231012 K10231019 K10231027 K10231130 K10231207 K10240104 K10240116 K10240125 K10240222 K10240327 K10240404 K10240516 K10240523 K10240606 K10240711 K10240725 K10240822 K10240829 K11230608

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0866-2025
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 24, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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