8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
FDA Device Recall #Z-0856-2025 - Class II, December 19, 2024
Recall Summary
| Recall Number | Z-0856-2025 |
| 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 | 7,132 |
Product Description
8MM,MARYLAND BIPOLAR FORCEPS,IS4000 ¿ REF 470172
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: 470172 Part Number: 470172-17 UDI-DI code: 00886874112281 Batch Numbers: K10221204 K10230219 K10230226 K10230302 K10230310 K10230427 K10230518 K10230525 K10230601 K10230608 K10230615 K10230622 K10230629 K10230913 K10231019 K10231123 K10240222 K10240327 K10240404 K10240418 K10240425 K10240502 K10240711 K11231019 K11231116 K11240502 K11240711
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.