Quick Facts at a Glance
- Recall Date
- December 15, 2025
- Hazard Level
- HIGH
- Brand
- Intuitive Surgical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Intuitive Surgical
- Product type
- Access Port Kit
- Model numbers
- 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
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 15, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Access Port System tray may develop cracks potentially resulting in a sterility breach.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Intuitive Surgical, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The da Vinci SP Access Port Kit is used in robotic-assisted surgeries to enhance the surgical approach through minimally invasive techniques. Surgeons and healthcare providers buy these kits to perform complex surgeries with precision and reduced recovery time for patients.
Why This Is Dangerous
Cracks in the Access Port System tray can compromise the sterility of surgical instruments, increasing the risk of postoperative infections. This defect can occur during normal handling and use of the device.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must address this recall urgently to prevent potential health risks associated with surgical procedures.
Practical Guidance
How to identify if yours is affected
- Check the reference numbers on the Access Port Kit: 430073 or 430075.
- Verify the lot numbers against the list provided by the manufacturer.
- Consult with your healthcare provider regarding the use of the product.
Where to find product info
Reference numbers and lot numbers can typically be found on the product packaging or the device itself.
What timeline to expect
Expect refund processing to take approximately 4-6 weeks after returning the device.
If the manufacturer is unresponsive
- Reach out to Intuitive Surgical again for follow-up.
- Contact the FDA if there is still no response.
How to prevent similar issues
- When purchasing surgical devices, always check for recent recalls or safety alerts.
- Look for certifications indicating sterility and safety standards.
- Ensure proper handling and storage of surgical instruments to maintain sterility.
Documentation advice
Keep records of your purchase, any correspondence with the manufacturer, and documentation of the recall for future reference.
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Product Details
The recall involves da Vinci SP Access Port Kits with reference numbers 430073 (2.7-4cm) and 430075 (2.7-7cm). These products were distributed worldwide, including the US and countries across Europe and Asia, and were sold at multiple retailers.
Key Facts
- Models affected: 430073 and 430075
- Potential for sterility breach
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Safety Guide
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