Intuitive Surgical, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0870-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401

Product Classification:

Class II

Date Initiated: December 19, 2024

Date Posted: January 22, 2025

Recall Number: Z-0870-2025

Event ID: 95938

Reason for Recall:

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

Status: Ongoing

Product Quantity: 5,576

Code Information:

Model Number: 470401 Part Number: 470401-07 UDI-DI code: 00886874112670 Batch Numbers: K10230129 K10230205 K10230212 K10230226 K10230323 K10230405 K10230413 K10230420 K10230504 K10230608 K10230630 K10230706 K10230713 K10230803 K10230810 K10230817 K10230928 K10231005 K10231019 K10231027 K10231102 K10230112 K10240125 K10240208 K10240222 K10240327 K10240411 K10240523 K10240606 K10240620 K10240627 K10240702 K10240711 K10240725 K11240112 Model Number: 470401 Part Number: 470401-08 UDI-DI code: 00886874112670 Batch Numbers: K10230914 K10231012 K10240327 K10240509 K10240523 K10240530

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

Voluntary or Mandated:

Voluntary: Firm initiated