HIGH

Intuitive Surgical Recalls Ion Vision Probe Bag Over Sterility Risk

Intuitive Surgical recalled 110,580 Ion Vision Probe Bags on December 4, 2025, due to compromised sterile seals. The recall affects devices distributed throughout the United States and several countries including Australia and Germany. Patients and healthcare providers should stop using the product immediately.

Quick Facts at a Glance

Recall Date
December 4, 2025
Hazard Level
HIGH
Brand
Intuitive Surgical
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
Nationwide (50 states)
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Intuitive Surgical, Inc. or your healthcare provider for instructions

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Product Details

The Ion Vision Probe Bag, model number 490127, is a single-use device designed for use with the Ion Endoluminal System. The product was distributed in the U.S. and internationally, with a total of 110,580 units recalled.

The Hazard

The recall stems from concerns that the sterile pouch seal of the Vision Probe Bags may be compromised. This defect increases the risk of infection or contamination during medical procedures.

Reported Incidents

There have been no reported injuries or incidents associated with this recall as of the report date.

What to Do

Stop using the Ion Vision Probe Bag immediately. Contact Intuitive Surgical or your healthcare provider for further instructions regarding the recall and potential returns.

Contact Information

For more information, contact Intuitive Surgical at 1-800-XXXX-XXXX or visit their website. Additional details can be found on the FDA recall page.

Key Facts

  • Recall date: December 4, 2025
  • Quantity recalled: 110,580 units
  • Affected countries: U.S., Australia, Germany, and more
  • Classification: Class II
  • Risk level: High
View Original Recall on FDA - Medical Devices

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeEndoscopic Vision Probe Bag
Sold At
Multiple Retailers

Product Details

Model Numbers
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 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DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM0125300
Affected States
Nationwide
Report Date
January 28, 2026
Recall Status
ACTIVE

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