Reported Jan 21, 2026 · Ongoing

da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075…

Intuitive Surgical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd · Sunnyvale, CA · 94086-5304

Is this the product you have?

  • da Vinci SP, SP Access Port Kit
  • Large Incision Reference Numbers
    • 430073 (2.7-4cm
    • SP1098
    • Box) & 430075 (2.7-7cm
    • SP1098
    • Box)
Lot codes and dates
  • REF430073
  • UDI00886874119549
  • Lot Numbers

    86 of 86 codes

    • 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
  • U81240905 U81240911 U82231219 REF430075
  • UDI00886874119556
  • Lot Numbers
    • U81240125
    • U80240201
    • U80240222
    • U80240125
    • U81240215
    • U81240208
    • U80240208
    • U81240201
    • U81240229
    • U80240326
    • U80240529
    • U80240229
    • U81240222
    • U80240711
    • U81240606
    • U80240606
    • U80240812
    • U80240731
    • U80240917
    • U10241107
    • U80241003
    • U10241217
    • U10250123
    • U10250305
    • U10250219
    • U10250102
    • K10250313
    • U10250414
    • U10250423
    • K10250529
    • K10250522
    • U10250529
    • K10250701
    • K10250702
    • K10250717
    • 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
Amount recalled
41,526 units

Where it was sold

Why it was recalled

Access Port System tray may develop cracks potentially resulting in a sterility breach.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.