Class II U.S. Food and Drug Administration

Intuitive Surgical, Inc. Brand Name: Ion Endoluminal System Product Name: Ion Vision recall: Due to probe bags that may have a compromised or incomplete sterile pouch seal

Recall published 9 months ago

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

The hazard: Harmful chemical exposure

The hazard here is chemical rather than mechanical, so the right response is to stop using the product and to ventilate or clean anywhere it has been applied.

What the notice says: Due to probe bags that may have a compromised or incomplete sterile pouch seal.

Why it matters: A chemical that should not be present at this level was found in the product. Depending on the substance, the concern may be a burn or irritation on contact, or a long-term risk from repeated exposure.

Symptoms and when to call a doctor

For a splash or spill, rinse the skin or eyes with running water for 15 to 20 minutes and remove contaminated clothing. If the product was swallowed, or if there is any trouble breathing, call Poison Control on 1-800-222-1222, which operates free and around the clock — or 911 if the person is collapsing, struggling to breathe or unconscious. Take the container or a photo of the label with you to any appointment.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-1134-2026
Published
January 28, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Intuitive Surgical, Inc.
Product type
Medical devices
Units affected
110580
Distribution
Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming
Made in
United States
Lot / code info
Lot Code: UDI: 00886874119594 GTIN: 0886874119594 FDA Medical Device Listing Number: D414014 Part Number: 490127-01 Batch Numbers: DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232816 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01232817 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233001 DM01233…
UPC codes
0886874119594, 00886874119594

Products covered by this recall

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

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 0886874119594
  • 00886874119594

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • UDI

Model or item number

On the rating label, the box or the instruction sheet.

  • 490127 Software Version
  • VP

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Chemical

Intuitive Surgical, Inc. — The hazard here is chemical rather than mechanical, so the right response is to stop using the product and to ventilate or clean anywhere it has been applied.

  1. Stop using the product and keep it away from children and pets.
  2. Keep the container — the lot code on it is what a refund claim and any medical follow-up both depend on.
  3. If anyone has symptoms, call Poison Control on 1-800-222-1222 rather than guessing.
  4. Do not pour it down a drain or into a bin without checking local hazardous-waste rules, and never mix it with another cleaner.

If the claim stalls

Most recall claims are paid without argument. The ones that stall usually stall for a reason you can fix.

  • Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.
  • Give it ten working days, then chase in writing and quote your claim reference.
  • If the company is unresponsive or has stopped trading, report it to the CPSC at SaferProducts.gov, and try the retailer in parallel.
  • Paid by card? A chargeback for goods that are unfit for sale is a legitimate fallback once the company has had a fair chance.

Company contact: Intuitive Surgical, Inc. — 1266 Kifer Rd, Sunnyvale, CA, 94086-5304

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Intuitive Surgical, Inc. medical devices recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 0886874119594, 00886874119594; lot code UDI; model number 490127 Software Version, VP. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the product and keep it away from children and pets.

Can I get my money back?

Check you used the recall channel rather than ordinary customer support — the two queues rarely talk to each other.

Which states were affected?

The notice lists Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii and others.

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