FDA recall, , Moderate risk
Intuitive Surgical Ion Endoluminal System Vision Probe Bags
The Ion Vision Probe Bag may have a compromised or incomplete sterile pouch seal.
Summary by Recall Canary from the FDA notice
What happened
Intuitive Surgical, Inc., of Sunnyvale, California, began a recall on December 4, 2025, of the Ion Vision Probe Bag, a part of the Ion Endoluminal System, a robotically assisted platform for minimally invasive peripheral lung biopsy. The recall was added to the FDA's Enforcement Report on January 21, 2026, because the probe bags may have a compromised or incomplete sterile pouch seal.
The product was distributed in the United States and in Australia, China, France, Germany, Italy, Japan, South Korea, Spain, Switzerland, and the United Kingdom.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your bag affected?
Match the model number and lot code listed under your product.
Ion Vision Probe Bag
- Model number
- 490127
- Lot code
- DM01232816
- DM01232817
- DM01233001
- DM01233002
- DM01233622
- DM01233623
- DM01233823
- DM01233824
- DM01234116
- DM01234117
- DM01234327
- DM01234328
- DM01234624
- DM01234718
- DM01234818
- DM01234819
- DM1225001
- DM1230443
- DM1231118
- DM1231119
- DM1231120
- DM1231355
- DM1231356
- DM1231357
- DM1231701
- DM1231702
- DM1232005
- DM1232006
- DM1232120
- DM1232121
- DM01252527
- DM01242617
- DM01244230
- DM01241638
- DM01240221
- DM01253518
- DM01253002
- DM01252828
- DM01252526
- DM01252722
- DM01251821
- DM01251820
- DM01252224
- DM01252339
- DM01252225
- DM01251736
- DM01250930
- DM01251735
- DM01250822
- DM01244035
- DM01244229
- DM01250539
- DM01250225
- DM01244621
- DM01250224
- DM01241125
- DM01244421
- DM01244620
- DM01244422
- DM01244420
- DM01244228
- DM01244125
- DM01244124
- DM01241639
- DM01240819
- DM01244034
- DM01243829
- DM01243830
- DM01243221
- DM01243720
- DM01242925
- DM01242616
- DM01241420
- DM01240116
- DM01243721
- DM01241124
- DM01243220
- DM01240818
- DM01242824
- DM01242924
- DM01240117
- DM01240631
- DM01240630
- DM01240220
- 12326030
Recall details
- Company began the recall
- Sold in
U.S.: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Maryland, 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, and Wyoming. O.U.S.: Australia, China, France, Germany, Italy, Japan, South Korea, Spain, Switzerland, and United Kingdom
- Company
- Intuitive Surgical, Inc.Sunnyvale, California
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98215
- Recall number
- Z-1134-2026
All recalls from Intuitive Surgical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
