Intuitive Surgical da Vinci SP Access Port Kit Recall: Cracks Risk Sterility Breach
Intuitive Surgical recalls da Vinci SP Access Port Kits with reference numbers 430073 and 430075 due to potential cracks causing sterility breaches. Affected units include specific lot numbers and sizes.
Lower-risk recall
Access Port System tray may develop cracks potentially resulting in a sterility breach.
Contact the company
What happened, in plain English
Intuitive Surgical is recalling da Vinci SP Access Port Kits that may develop cracks, risking sterility breaches during surgery. This could lead to infections if the surgical site isn't properly sterilized. Read more at govinfonow.com/recall/50429-intuitive-surgical-da-vinci-sp-access-port-kit-recall-cracks.
Source Summary by GovInfoNow · govinfonow.com/recall/50429-intuitive-surgical-da-vinci-sp-access-port-kit-recall-cracks · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1096-2026
Cite this page
“Intuitive Surgical da Vinci SP Access Port Kit Recall: Cracks Risk Sterility Breach.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50429-intuitive-surgical-da-vinci-sp-access-port-kit-recall-cracks. Based on FDA recall #Z-1096-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1096-2026%22&limit=1).
Why it’s dangerous
The Access Port System tray may crack over time, which could compromise the sterile environment during surgery. This might lead to contamination of the surgical site and potential infections.
Who’s affected
Surgical teams using the da Vinci SP Access Port Kits with reference numbers 430073 or 430075 are most at risk. These kits are used in minimally invasive surgery procedures.
How to tell if you have this one
Check for reference numbers 430073 (2.7-4cm, SP1098) or 430075 (2.7-7cm, SP1098) with specific lot numbers listed in the recall notice.
- Brand
Intuitive Surgical- Category
Medical device
What to do — step by step
Check Product Details
Identify the reference number and lot numbers listed in the recall notice to confirm if your kit is affected.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 38 states.
FDA distribution: “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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: 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.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1096-2026 (December 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1096-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.