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.

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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DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1232121 DM1231702 DM1231702 DM1231702 DM1231702 DM1230443 DM1231355 DM1232006 Part Number: 490127-02 Batch Numbers: DM01252527 DM01252527 DM01252527 DM01252527 DM01242617 DM01244230 DM01241638 DM01241638 DM01240221 DM01240221 DM01240221 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253518 DM01253002 DM01253002 DM01253002 DM01253518 DM01253002 DM01253518 DM01253002 DM01253518 DM01253002 DM01253518 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253518 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253002 DM01253518 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 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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HIGH

Honda 2025 CR-V Hybrid Recall for Fuel Hose Installation Could Cause Fire (TLS)

Honda recalls 2025 CR-V Hybrid vehicles sold through Honda dealers nationwide after finding an improperly installed fuel feed hose that may leak. The recall is identified by Honda as TLS. Dealers will replace the fuel feed hose and install a new connector cover at no charge. Owners should contact Honda at 1-888-234-2138 for service.

Honda
A fuel
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Mercedes-Benz GLE 450E 4MATIC Recall for Rearview Mirror Attachment (2025)

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Mercedes-Benz
A detached
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Mazda CX-30 2025 Air Bag Software Recall for SAS Unit (7525E)

Mazda North American Operations recalls 2024-2025 Mazda3 and CX-30 vehicles after SAS units may deactivate airbags due to a low battery condition. Dealers will reprogram the SAS unit or replace it at no charge. Owner notification letters were mailed July 24, 2025.

Mazda
Air bags
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HIGH

Kia K5 Recalled Over Risk of Detached Trim Pieces

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Kia America, Inc.
Detached trim
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Kia Telluride Exterior Trim Recall for 2023-2025 Models (2027 Recall)

Kia America, Inc. is recalling 2023-2025 Kia Telluride SUVs sold through Kia dealers nationwide after interim notices warned that door belt molding trim can delaminate and detach. A detached trim piece can become a road hazard for other vehicles and increase the risk of a crash. Owners should contact Kia customer service at 800-333-4542 for inspection and repair.

Kia
A detached
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HIGH

Ford Expedition Recalled for Engine Oil Leak Hazard

Ford Motor Company recalled certain 2024-2025 Expedition vehicles due to a misaligned engine cup plug. This defect can lead to rapid oil leaks, increasing the risk of engine stalls and fires. The recall affects models with 3.5L GTDI engines, with notifications mailed on May 22, 2025.

Ford Motor Company
A rapid
Read more