Recall Z-1096-2026 ยท NAY System, Surgical, Computer Controlled Instrument
Intuitive Surgical, Inc.
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
| Date | Jan 15, 2026 (initiated Dec 15, 2025) |
| Status | Open, Classified |
| Reason | Access Port System tray may develop cracks potentially resulting in a sterility breach. |
| Root cause | Packaging change control |
| Action | On December 15, 2025, Intuitive Surgical Inc. issued a Urgent: Medical Device Recall Notification via mail and email. Intuitive asked consignees to take the following actions: 1. Follow the warning provided in the SP Access Port Kit User Manual Addendum 2. Identify Affected Product: Please inspect the product label to confirm the Part Number and Lot Number. 3. If the product label indicates a Lot Number within the affected range specified, proceed with the following actions 4 and 5 below. 4. Quarantine affected inventory: Immediately segregate and quarantine all affected units to prevent |
| Quantity | 41,526 units |
| Distribution | Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Jersey |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K202571 | da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories Intuitive Surgical, Inc., Nov 12, 2020 |