Quick Facts at a Glance
- Recall Date
- December 19, 2025
- Hazard Level
- HIGH
- Brand
- Boston Scientific
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 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
- Boston Scientific
- Product type
- Stent and Electrocautery-Enhanced Delivery System
- Model numbers
- Material Number (UPN): M00553690, UDI-DI: 191506008093, Lot Numbers: 35960775, 35960777, 35962525, 36100561, 36101748, 36111316 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 19, 2025
Reported by FDA DEVICE
February 11, 2026
RecallRadar source check
February 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: N/A
About This Product
The AXIOS Stent is used in various endoscopic procedures to maintain the patency of lumens or ducts. It is intended for patients requiring stent placement due to various medical conditions.
Why This Is Dangerous
Issues with deploying the AXIOS Stent can lead to complications such as prolonged procedures and the need for further surgical intervention. This creates significant risks for patients during treatment.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Affected patients may face delays in treatment or additional medical procedures, which could lead to increased healthcare costs and extended recovery times.
Practical Guidance
How to identify if yours is affected
- Locate the material number on the packaging or the device itself.
- Check if your stent matches the lot numbers listed in the recall.
- Consult your healthcare provider for further confirmation.
Where to find product info
The material number and lot numbers are typically printed on the packaging and the stent label.
What timeline to expect
Expect a refund or replacement processing timeline of approximately 4-6 weeks after following the return instructions.
If the manufacturer is unresponsive
- Document your communication attempts with the manufacturer or healthcare provider.
- Reach out to relevant health authorities or consumer protection agencies for assistance.
How to prevent similar issues
- Always check for recalls before using medical devices.
- Consult with healthcare providers about the latest safety information regarding medical products.
Documentation advice
Keep records of your stent's material number, lot number, and any correspondence regarding the recall.
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Product Details
The AXIOS Stent and Electrocautery-Enhanced Delivery System measures 8mm x 8mm. It was distributed worldwide, including in the U.S. and Puerto Rico, from multiple retailers.
Key Facts
- Class I recall
- Stop using the device immediately
- Contact healthcare provider for instructions
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Safety Guide
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