8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
FDA Device Recall #Z-0870-2025 — Class II — December 19, 2024
Recall Summary
| Recall Number | Z-0870-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 19, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Intuitive Surgical, Inc. |
| Location | Sunnyvale, CA |
| Product Type | Devices |
| Quantity | 5,576 |
Product Description
8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401
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
Lot / 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
Other Recalls from Intuitive Surgical, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2310-2026 | Class II | Brand Name: Da Vinci 5 Product Name: ASSY,DV5 ... | Apr 24, 2026 |
| Z-2046-2026 | Class II | Brand Name: Da Vinci X and Da Vinci Xi Product... | Apr 2, 2026 |
| Z-1855-2026 | Class I | Intuitive 8 mm SureForm 30 Gray Reloads Refer... | Mar 11, 2026 |
| Z-1355-2026 | Class II | da Vinci 5 Surgeon Console Viewer Display, ASSY... | Dec 30, 2025 |
| Z-1096-2026 | Class II | da Vinci SP, SP Access Port Kit, Large Incisio... | Dec 15, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.