Recall Z-1134-2026 ยท EOQ Bronchoscope (Flexible Or Rigid)
Intuitive Surgical, Inc.
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System Cart and Controller that are used to navigate a flexible Catheter within the pulmonary tract using endoscopic visualization
| Date | Jan 21, 2026 (initiated Dec 4, 2025) |
| Status | Open, Classified |
| Reason | Due to probe bags that may have a compromised or incomplete sterile pouch seal. |
| Root cause | Process control |
| Action | On 12/19/2025, the firm emailed to customer an "Urgent Medical Device Recall" letter informing them that Intuitive has identified that some Vision Probe Bags may have a compromised or incomplete sterile pouch seal. Investigation determined that during the supplier manufacturing and packaging process, the Vision Probe Bag is placed into a separate sterile pouch for sealing. During this step, air trapped inside the Vision Probe Bag can remain within the pouch and expand during sterilization, which may place stress on the sterile-pouch seals and result in partial seal failure, creating a potentia |
| Quantity | 110580 |
| 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, France, Germany, Italy, Japan, South Korea, Spain, Switzerl |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212048 | Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) Intuitive Surgical, Inc., Aug 26, 2021 |