Intuitive Surgical Ion Vision Probe Bag Recall: Compromised Sterile Pouch Seal
Intuitive Surgical recalls Ion Vision Probe Bags (model 490127) due to potential compromised sterile pouch seals. These single-use bags, used with their robotic surgery system, may not be sterile after packaging. Affected units include specific batch numbers listed in the recall notice.
Lower-risk recall
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
Contact the company
What happened, in plain English
Intuitive Surgical is recalling Ion Vision Probe Bags (model 490127) because some units may have a compromised or incomplete sterile pouch seal. This could lead to the bags not being sterile when used, potentially causing infections during surgery. The bags are part of their robotic surgical system. Read more at govinfonow.com/recall/50533-intuitive-surgical-ion-vision-probe-bag-recall-compromised-sterile-pouch.
Source Summary by GovInfoNow · govinfonow.com/recall/50533-intuitive-surgical-ion-vision-probe-bag-recall-compromised-sterile-pouch · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1134-2026
Cite this page
“Intuitive Surgical Ion Vision Probe Bag Recall: Compromised Sterile Pouch Seal.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50533-intuitive-surgical-ion-vision-probe-bag-recall-compromised-sterile-pouch. Based on FDA recall #Z-1134-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1134-2026%22&limit=1).
Why it’s dangerous
The Vision Probe Bag is a single-use sterile pouch that holds the Vision Probe (a surgical tool) during procedures. If the pouch seal is compromised or incomplete, the bag may not maintain sterility after packaging. This could lead to contamination of the surgical tool during procedures, increasing infection risk.
Who’s affected
Users of Intuitive Surgical's robotic surgery systems who own or use the Ion Vision Probe Bags (model 490127) are affected. The risk is low because the bags are single-use and the seal issue is unlikely to cause serious injury if the bag is used properly.
How to tell if you have this one
Check for the model number 490127 on the bag. Affected units include specific batch numbers listed in the recall notice, such as DM01232816 through DM01253002. The bags are part of Intuitive Surgical's robotic surgery system.
- Brand
Intuitive Surgical- Product
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version- Category
Medical device
What to do — step by step
Check Your Bag
Look for the model number 490127 on the Vision Probe Bag. Affected units have batch numbers from DM01232816 to DM01253002.
Contact Intuitive Surgical
If your bag is affected, contact Intuitive Surgical directly for instructions on how to return it.
Where it went and when
Where it was distributed
Distributed in 50 states and D.C., and outside the U.S.
FDA distribution: “U.S.: AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MA, MD, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, and WY. O.U.S.: Australia, China,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 55 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-1134-2026 (December 4, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1134-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.