Intuitive Surgical, Inc.: Device Recall
Recall #Z-1134-2026 · 12/04/2025
Recall Details
- Recall Number
- Z-1134-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Intuitive Surgical, Inc.
- Status
- Ongoing
- Date Initiated
- 12/04/2025
- Location
- Sunnyvale, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 110580
Reason for Recall
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
Product Description
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 for diagnostic and therapeutic procedures. The Ion Fully Articulating Catheter (referred to as the Catheter) consists of the housing, sensor, input discs, shaft, tool channel, and tip. The Catheter is installed on the carriage of the arm. The Catheter is provided non-sterile and is a multi-use device. The Ion Peripheral Vision Probe (referred to as the Vision Probe or VP) is an endoscope that is compatible with, and inserted into, the Catheter tool channel. The VP provides direct visualization of the patient s airways during navigation. The VP attaches to the arm and has a collar that is rotated and then pulled to release it from the arm. The VP is provided non-sterile and is a multi-use device that can be used up to 5 times. The Vision Probe Bag (referred to as VPB) installs over the Instrument Arm for temporary storage of the VP when it is not inserted within the Catheter tool channel. The VPB is a single-use device provided sterile (folded within a pouch) by Ethylene Oxide (EO) sterilization method. Refer to HHE for additional details. Component: N/A
Distribution Pattern
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, Switzerland, and United Kingdom
Other Recalls by Intuitive Surgical, Inc.
- Class II: Risk 12/15/2025
- Class II: Risk 11/07/2025
- Class II: Risk 02/26/2025
- Class II: Risk 12/19/2024
- Class II: Risk 12/19/2024