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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About This Product

The Ion Vision Probe Bag is a single-use device designed for temporary storage of the Ion Peripheral Vision Probe during endoscopic procedures. It is used in conjunction with the Ion Endoluminal System for minimally invasive lung biopsies.

Why This Is Dangerous

The hazard arises from the possibility of a compromised sterile pouch seal, which can lead to contamination and increase the risk of infection during medical procedures.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers who have purchased this product face potential safety risks during medical procedures. The urgency for action is high, as the use of compromised bags could lead to severe health complications.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on the packaging.
  2. Verify if the batch number matches the recalled lots.
  3. Confirm that the product is the Ion Vision Probe Bag.

Where to find product info

The model and batch numbers can typically be found on the product packaging or user manual.

What timeline to expect

Expect a refund processing time of approximately 4-6 weeks.

If the manufacturer is unresponsive

  • Contact Intuitive Surgical again for updates.
  • Document your communications and any responses received.
  • Consider reaching out to consumer protection agencies if issues persist.

How to prevent similar issues

  • Always verify the sterility of medical devices before use.
  • Look for clear labeling regarding sterility and expiration dates.
  • Consult healthcare providers about the safety of medical devices.

Documentation advice

Keep records of any correspondence regarding the recall, including emails and phone call logs. Save packaging and product details as evidence.

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.

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

Related Recalls

Health & Personal Care
HIGH

Intuitive Surgical Recalls da Vinci 5 Display Over High Injury Risk

Intuitive Surgical recalled 47 da Vinci 5 Surgeon Console Viewer Displays on December 30, 2025. The devices may lose display functionality, risking surgical injury. Healthcare providers should stop using the consoles immediately and follow recall instructions.

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Intuitive Surgical Recalls da Vinci SP Access Port Kits Over Sterility Risk

Intuitive Surgical recalled 41,526 da Vinci SP Access Port Kits on December 15, 2025, due to potential cracks in the tray that could breach sterility. The recall affects models 430073 and 430075, distributed worldwide including across the US and various countries. Patients and healthcare providers must stop using these devices immediately and follow manufacturer instructions for return.

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Intuitive Surgical da Vinci S/Si Monopolar Curved Scissors Recall for 86,904 Units Worldwide (2025)

Intuitive Surgical recalled 86,904 da Vinci S and Si Monopolar Curved Scissors instruments sold worldwide to hospitals and surgical centers. The recall cites increased complaints of broken or frayed grip cables on reusable instruments. Healthcare facilities should stop using the device immediately and follow the manufacturer’s recall instructions.

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Intuitive Surgical da Vinci S, Si Grasping Retractor Instrument Recalled for 2,660 Units (2026)

Intuitive Surgical recalled 2,660 da Vinci S/Si Grasping Retractor Instruments worldwide after increased complaints of broken or frayed grip cables. The devices transmit motion from input disks to the distal tip and are used in robotic surgery. Hospitals and surgical centers should stop using the device immediately and follow recall instructions from the manufacturer.

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Intuitive Surgical Recalls 2,095 da Vinci S, Si EndoWrist Tenaculum Forceps Instrument (2025)

Intuitive Surgical recalled 2,095 units of the da Vinci S, Si EndoWrist Tenaculum Forceps Instrument distributed nationwide in the United States and in multiple countries after reports of frayed or broken pitch cables. The defect can compromise instrument control during surgery. Hospitals and surgeons should stop using the device immediately and follow recall instructions from Intuitive Surgical.

Intuitive Surgical
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Health & Personal Care
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Intuitive Surgical da Vinci S/Si EndoWrist Recall 6,152 Instruments for Pitch Cable Frays (2026)

Intuitive Surgical recalled 6,152 da Vinci S, Si Permanent Cautery Hook Instruments distributed to U.S. hospitals and clinics overseas. The defect involves frayed or broken pitch cables. Healthcare facilities should stop using the instruments immediately and follow manufacturer recall instructions. If you operate with these tools, consult your supplier or Intuitive Surgical for next steps.

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