Reported Jan 28, 2026 · Ongoing
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version:…
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd · Sunnyvale, CA · 94086-5304
Is this the product you have?
- Brand NameIon
- Endoluminal System Product NameIon
- Vision Probe Bag Model/Catalog Number490127
- Software VersionN/A
- Product DescriptionThe 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
- ComponentN/A
- Lot codes and dates
- Lot CodeUDI: 00886874119594
- GTIN0886874119594
- FDA Medical Device Listing NumberD414014
- Part Number490127-01
- Batch Numbers
2,902 of 2,902 codes
DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816DM01232816
- DM1231355 DM1232006 Part Number490127-02
- Batch Numbers
156 of 156 codes
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
- Amount recalled
- 110580
Where it was sold
Why it was recalled
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
This product could cause temporary or reversible health problems — stop using it.
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