Home / Recalls / Intuitive Surgical, Inc. / Z-0857-2025

Z-0857-2025 Class II Ongoing

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

FDA device recall Z-0857-2025 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: 373.

Recall Details

Product Type: Devices
Report Date: Jan 22, 2025
Initiation Date: Dec 19, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 373

Product Description

8MM,RESANO FORCEPS,IS4000 ¿ REF 470181

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: 470181 Part Number: 470181-09 UDI-DI code: 00886874112304 Batch Numbers: K10230601 K10230608 K10230824 K10230928 K10231012 K10231027 K10240118 K10240222 K10240516 K10240711 K10240725 K10240801

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0857-2025
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.

Other recalls by Intuitive Surgical, Inc.

Z-2310-2026 Class II — Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog… (Apr 24, 2026)
Z-2521-2026 Class II — Da Vinci ASSY, PSS, SP1098, Part Number: 380601 (Apr 22, 2026)
Z-2046-2026 Class II — Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical… (Apr 2, 2026)
Z-1855-2026 Class I — Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and… (Mar 11, 2026)
Z-1355-2026 Class II — da Vinci 5 Surgeon Console Viewer Display, ASSY, DV5 CONSOLE, IS5000, Part… (Dec 30, 2025)
Z-1096-2026 Class II — da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073… (Dec 15, 2025)
Z-1697-2026 Class II — Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name… (Dec 9, 2025)
Z-1700-2026 Class II — Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci… (Dec 9, 2025)
Z-1701-2026 Class II — Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da… (Dec 9, 2025)
Z-1699-2026 Class II — Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci… (Dec 9, 2025)