Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A

FDA device recall Z-1134-2026 · posted 2026-01-21 · Open, Classified

Recall details

Recalling firm

Intuitive Surgical, Inc.

Reason for recall

Due to probe bags that may have a compromised or incomplete sterile pouch seal.

Action taken

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)

Root cause

Process control

Status

Open, Classified

Product code

EOQ

Quantity affected

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

Date initiated

2025-12-04

Date posted

2026-01-21

Location

Sunnyvale, CA

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