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RecallWatchMedical Device Safety
Class IIOngoingZ-1134-2026

Intuitive Surgical, Inc. recalls Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog N…

Intuitive Surgical, Inc.Sunnyvale, CA, United StatesReported Jan 28, 2026 · 5 months ago
Legal News Analyst ·

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • 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
    UDI 00886874119594GTIN 0886874119594
    400 affected lots
    008868741195940886874119594D414014490127-01DM01232816DM01232816DM01232816DM01232816
    +392 moreDM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01232817DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233001DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233002DM01233622DM01233622DM01233622DM01233622DM01233622DM01233622

What the firm is doing

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)

DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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