Quick Facts at a Glance
- Recall Date
- August 5, 2025
- Hazard Level
- HIGH
- Brand
- Boston Scientific
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
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
- Inflation Device for Balloon Dilation Catheters
- Model numbers
- M0062251200, M0062251210, M0062251220, M0062251230, M0062251240, M0062251260, M0062251290, M0062251300 +4 more
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 5, 2025
Reported by FDA DEVICE
September 17, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
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: Letter
About This Product
The Encore 26 Inflation Device is part of a system used to inflate and monitor pressure in balloons during dilation procedures.
Why This Is Dangerous
Foreign material particles could migrate from the inflation device into the catheter, potentially affecting device function.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects medical facilities handling balloon dilation procedures and could impact patient safety and procedure timelines.
Practical Guidance
How to identify if yours is affected
- Compare against recall list on FDA page Z-2536-2025.
- Verify batch numbers if present.
Where to find product info
FDA enforcement page for recall Z-2536-2025 and Boston Scientific customer service.
What timeline to expect
Notification by letter; refunds or replacements to follow per manufacturer timelines.
If the manufacturer is unresponsive
- Document all attempts to contact; escalate to FDA/CMC if needed; seek alternative supplier or interim devices as advised by clinicians.
- Engage hospital risk management for guidance.
How to prevent similar issues
- Verify device compatibility for balloon dilation catheters before use.
- Maintain updated recall lists from FDA and manufacturer.
- Establish standard operating procedures for device recalls in clinical settings.
Documentation advice
Keep recall notice, contact logs, and any replacement communications for records.
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Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- UPNs include M0062251200 to M0062251370
- High-hazard medical device
- No injuries reported in data
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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