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
- Model numbers
- H74904526011, H74904526052, M0067101140, M001151050, M001151062, M00566670
- 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 used to inflate and deflate balloon dilatation catheters during interventional procedures in cardiology and peripheral interventions.
Why This Is Dangerous
Foreign material could migrate from affected devices into the balloon catheter, potentially compromising the procedure.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Medical professionals must halt use immediately. Potential need for device replacement or additional monitoring during procedures.
Practical Guidance
How to identify if yours is affected
- Check device documentation for UPN on the package or device label.
- Consult hospital inventory and device tracking systems for recall status.
Where to find product info
Official recall notice from FDA and manufacturer communications. Contact your healthcare facility’s biomedical engineering department for identification.
What timeline to expect
Refund or replacement timing will be provided by the manufacturer; no specific window given in the data.
If the manufacturer is unresponsive
- Escalate to hospital risk management.
- File a formal incident report with the device manufacturer and FDA if applicable.
How to prevent similar issues
- Verify device clearance before use in any procedure.
- Establish a recall management plan with procurement and biomed teams.
- Monitor for further recall updates from FDA and Boston Scientific.
Documentation advice
Document recall notice, device serial numbers, dates of procedures, and any communications with the manufacturer or hospital.
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Product Details
Brand: Boston Scientific. Product: Encore 26 Inflation Device. Material Numbers (UPN): H74904526011; H74904526052; M0067101140; M001151050; M001151062; M00566670. Quantity: 39,739 units. Classification: Class II. Distribution: Worldwide. Context: Interventional Cardiology and Peripheral Interventions.
Reported Incidents
No specific injuries or incidents are described in the provided data. The recall status is active with a high hazard level.
Key Facts
- 39,739 units recalled worldwide
- Status: Active recall
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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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