FDA DevicesClass II
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2....
Published: January 21, 2026Recall ID: Z-1096-2026Category: devicesCountry: US
Reason for Recall / Hazard
Access Port System tray may develop cracks potentially resulting in a sterility breach.
Product Description & Identification
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Affected Products
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Additional Source Details
| Field | Value |
|---|---|
| City | Sunnyvale |
| State | CA |
| Event id | 98187 |
| Address 1 | 1266 Kifer Rd |
| Code info | REF: 430073 UDI: 00886874119549 Lot Numbers: U80240110 K10250114 K10250305 K10250306 K10250313 K10250414 K10250424 K10250514 K10250522 K10250619 K10250626 K10250629 K10250630 K10250710 K10250716 K10250717 K10250731 K10250804 K10250806 K10250828 K10250904 K11250113 K11250807 K11250821 K11250828 K11250911 K12250821 U10241101 U10241115 U10250108 U10250207 U10250210 U10250307 U10250310 U10250313 U10250321 U10250325 U10250331 U10250414 U10250425 U10250506 U10250509 U10250521 U10250528 U10250604 U11241101 U11241121 U11241210 U11250123 U11250219 U11250404 U11250425 U11250521 U12250219 U80231207 U80231219 U80240118 U80240125 U80240201 U80240222 U80240306 U80240319 U80240402 U80240411 U80240417 U80240523 U80240617 U80240620 U80240806 U80240812 U80240905 U80240911 U80241017 U80241025 U81231219 U81240118 U81240125 U81240306 U81240319 U81240402 U81240411 U81240417 U81240617 U81240620 U81240627 U81240806 U81240905 U81240911 U82231219 REF: 430075 UDI: 00886874119556 Lot Numbers: U81240125 U80240... [TRUNCATED] |
| Postal code | 94086-5304 |
| Report date | 20260121 |
| Product type | Devices |
| Product quantity | 41,526 units |
| Reason for recall | Access Port System tray may develop cracks potentially resulting in a sterility breach. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251215 |
| Initial firm notification | Letter |
| Center classification date | 20260115 |
Overview
- Recalling FirmIntuitive Surgical, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Poland, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom.