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U.S. Department of Health and Human Services

Class 2 Device Recall Access Port Kit, Large Incision

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 Class 2 Device Recall Access Port Kit, Large Incisionsee related information
Date Initiated by FirmDecember 15, 2025
Date PostedJanuary 15, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1096-2026
Recall Event ID 98187
510(K)NumberK202571 
Product Classification System, surgical, computer controlled instrument - Product Code NAY
Productda Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Code Information 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 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
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd
Sunnyvale CA 94086-5304
For Additional Information ContactShahbaz Khan
1-408-5232443
Manufacturer Reason
for Recall		Access Port System tray may develop cracks potentially resulting in a sterility breach.
FDA Determined
Cause 2		Packaging change control
ActionOn 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 clinical use. 5. Return affected product. 6. Forward this notice to all individuals within your organization who need to be aware. 7. Complete the attached Acknowledgement Form immediately and return it to Intuitive via fax or email as instructed on the form. 8. Please retain a copy of this letter, place a copy with your affected system, and keep the acknowledgement form for your files. 9. Please inform Intuitive of any Adverse Events*/Serious Incidents** or quality problems. 10. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Quantity in Commerce41,526 units
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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NAY
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