FDA recall, , Moderate risk
Intuitive Surgical da Vinci SP Access Port Kit
The da Vinci SP Access Port Kit may develop cracks, potentially causing a sterility breach.
Summary by Recall Canary from the FDA notice
What happened
Intuitive Surgical, Inc., of Sunnyvale, California, recalled 41,526 units of the da Vinci SP Access Port Kit because the Access Port System tray may develop cracks, potentially resulting in a sterility breach. The recall began on December 15, 2025, and was added to the FDA's Enforcement Report on January 15, 2026.
The recalled kits were distributed worldwide, including in the United States and in 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, and the United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
- UDI-DI
- 00886874119549
- 00886874119556
- Lot code
- 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
- U81240215
- U81240208
- U80240208
- U81240201
- U81240229
- U80240326
- U80240529
- U80240229
- U81240222
- U80240711
- U81240606
- U80240606
- U80240731
- U80240917
- U10241107
- U80241003
- U10241217
- U10250123
- U10250305
- U10250219
- U10250102
- U10250423
- K10250529
- U10250529
- K10250701
- K10250702
- K11250814
- K10250807
- K11250813
- K10250605
- U80240611
- K10250327
- U80240425
- U10250312
- K10250515
- K11250515
- U10250318
- U80240724
- U10250115
- U10250326
- U80240130
- U80240627
- K10250113
- K11250529
- K10250723
- U80240717
- U80240215
- U10250501
- K10250403
- U10250515
- K12250904
Recall details
- Company began the recall
- Sold in
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, 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.
- Company
- Intuitive Surgical, Inc.Sunnyvale, California
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98187
- Recall number
- Z-1096-2026
- Quantity recalled
- 41,526 units
All recalls from Intuitive Surgical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
