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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Intuitive Surgical
- Product type
- Endoscopic Vision Probe Bag
- 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 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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 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 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- Sold at
- Multiple Retailers
- Where affected
- Nationwide
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 4, 2025
Reported by FDA DEVICE
January 28, 2026
RecallRadar source check
February 4, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check the model number on the packaging.
- Verify if the batch number matches the recalled lots.
- 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.
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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.
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
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