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…
Intuitive Surgical, Inc. · 4 Dec 2025
- Status
- Recall open, classified
- Why, in the FDA's words
- “Due to probe bags that may have a compromised or incomplete sterile pouch seal.”
- Recall began
- 4 Dec 2025
- Company
- Intuitive Surgical, Inc.
- Device type
- Product code (EOQ)
- Concerns
- K212048
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.