| | Class 2 Device Recall Ion Endoluminal System |  |
| Date Initiated by Firm | December 04, 2025 |
| Date Posted | January 21, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1134-2026 |
| Recall Event ID |
98215 |
| 510(K)Number | K212048 |
| Product Classification |
Bronchoscope (flexible or rigid) - Product Code EOQ
|
| Product | 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 |
| Code Information |
Lot Code: UDI: 00886874119594
GTIN: 0886874119594
FDA Medical Device Listing Number: D414014
Part Number: 490127-01
Batch Numbers:
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Part Number: 490127-02
Batch Numbers:
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Recalling Firm/ Manufacturer |
Intuitive Surgical, Inc. 1266 Kifer Rd Sunnyvale CA 94086-5304
|
| For Additional Information Contact | Shahbaz Khan 1-408-5232443 |
Manufacturer Reason for Recall | Due to probe bags that may have a compromised or incomplete sterile pouch seal. |
FDA Determined Cause 2 | 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 potential sterility breach.
Customers are instructed:
1. Identify affected product: Inspect the product label and confirm the product number and lot number.
a. Appendix A lists affected Part Numbers and Lot Numbers
b. Appendix B provides an example label highlighting the location of the Part Number and Lot Number.
2. If the label displays lot numbers within the affected range shown in Appendix A, inspect the product pouch seal. Do not use the product if the seal is compromised or has an incomplete seal and scrap the affected units in accordance with your facility s disposal procedures.
3. Contact Intuitive Customer Service to obtain credit for any scrapped units.
a. Product return to Intuitive is not required.
4. Retain a copy of this letter and the complete Acknowledgment Form for your records.
5. Ensure all relevant personnel within your facility are informed of this correction.
For Questions -
" North and South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: customerservice@intusurg.com.
" Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or eucs@intusurg.com
" South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or support.korea@intusurg.com
" Japan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) or csjapan@intusurg.com
" India: +1-800-103-6952 (9 am to 6 pm IT)
Taiwan: +0800-86-8181 (9 am to 6 pm CT)
|
| Quantity in Commerce | 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, Switzerland, and United Kingdom |
| Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = EOQ
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