8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194
FDA Device Recall #Z-0858-2025 - Class II, December 19, 2024
Recall Summary
| Recall Number | Z-0858-2025 |
| 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 | 38,438 |
Product Description
8MM,MEGA NEEDLE DRIVER,IS4000¿ REF 470194
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: 470194 Part Number: 470194-06 UDI-DI code: 00886874112342 Batch Numbers: K10221113 K10221128 K10221204 K10221212 K10221218 K10230112 K10230205 K10230212 K10230217 K10230824 K10240418 K10240502 K10240523 K10240718 K10240801 K11221212 K11230112 K11230217 K11240418 K12230112 K12230217 K16240702 U10230217 Model Number: 470194 Part Number: 470194-08 UDI-DI code: 00886874112342 Batch Numbers: K10230302 K10230310 K10230316 K10230323 K10230405 K10230420 K10230511 K10230525 K10230601 K10230608 K10230615 K10230622 K10230706 K10230713 K10230720 K10230727 K10230810 K10230817 K10230907 K10230914 K10230921 K10230928 K10231012 K10231019 K10231027 K10231102 K10231109 K10231123 K10231130 K10231207 K10231214 K10240104 K10240111 K10240118 K10240125 K10240202 K10240208 K10240215 K10240314 K10240327 K10240404 K10240425 K10240509 K10240515 K10240523 K10240606 K10240613 K10240620 K10240627 K10240702 K10240822 K11230302 K11230310 K11230323 K11230720 K11230727 K11230914 K11231012 K11231027 K11231109 K11240118 K11240125 K11240314 K11240404 K11240509 K11240620 K11240822 K12230302 K12230914 K12240404 K12240509 K12240620 U10230517
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-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... | 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 |
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.