Intuitive Surgical da Vinci SP Instrument Arm Drape Recall: Risk of Sterile Barrier Breach
Intuitive Surgical recalls da Vinci SP Instrument Arm Drape (REF 430013-12) due to potential tear during use, risking sterile barrier breaches. Affected units include all lots of this pouch.
Use caution until it’s fixed
The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
Contact the company
What happened, in plain English
Intuitive Surgical is recalling the da Vinci SP Instrument Arm Drape pouch (model 430013-12) because it may tear while draping the Patient Side Cart, potentially breaking the sterile barrier. This could lead to infections during surgery if not properly maintained. Read more at govinfonow.com/recall/69551-intuitive-surgical-da-vinci-sp-instrument-arm-drape-recall-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/69551-intuitive-surgical-da-vinci-sp-instrument-arm-drape-recall-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1906-2020
Cite this page
“Intuitive Surgical da Vinci SP Instrument Arm Drape Recall: Risk of Sterile Barrier Breach.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69551-intuitive-surgical-da-vinci-sp-instrument-arm-drape-recall-risk. Based on FDA recall #Z-1906-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1906-2020%22&limit=1).
Why it’s dangerous
The drape may tear during the draping process for the Patient Side Cart, which breaks the sterile barrier. This could allow bacteria to enter the surgical site, increasing infection risk for patients.
Who’s affected
Surgical teams using the da Vinci SP system are most at risk. Patients undergoing surgery with this drape could face infection risks if the sterile barrier is compromised.
How to tell if you have this one
Check for the model number 430013-12 on the pouch. This drape is sold with the da Vinci SP surgical system and is available in all lots.
- Brand
Intuitive Surgical- Category
Medical device
What to do — step by step
Check Drape Condition
Inspect the drape for tears or damage before use. If torn, stop using it immediately.
Contact Manufacturer
Reach out to Intuitive Surgical for guidance on handling the drape if you have concerns about sterility.
Where it went and when
Where it was distributed
Distributed in 17 states, and outside the U.S.
FDA distribution: “Updated information provided on 03/18/2020: FL, OH, TN, NJ, PA, MD, NY, CA, MN, NV, OR, HI, VA, TX, AL, CA, IL, CN, and NC. OUS: APAC (Asia Pacific) - South Korea” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, California, Florida, Hawaii, Illinois, Maryland, Minnesota, Nevada, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia.
Recall timeline
FDA terminated this recall 5.4 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this drape used in surgeries?
Yes, this drape is used during da Vinci SP surgical procedures to maintain sterility.
Similar recalls
Latest medical device recalls
Keep exploring
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-1906-2020 (October 25, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1906-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 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.