Quick Facts at a Glance
- Recall Date
- August 5, 2025
- Hazard Level
- HIGH
- Brand
- Boston Scientific
- Category
- Health & Personal Care
- Sold At
- Unknown
- At-Risk Groups
- GENERAL, PREGNANT, PETS
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/Deflation Device
- Model numbers
- M0062101180, M0062101600
- Sold at
- Unknown
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
NephroMax Kit with Encore 26 Inflation Device is used in urology to dilate and monitor pressure in balloons.
Why This Is Dangerous
Particles could migrate from the inflation device into the catheter, potentially compromising device integrity or patient safety.
Industry Context
This recall is not part of a broader industry pattern; it is specific to this device line.
Real-World Impact
High risk in invasive procedures; immediate action required to prevent potential contamination of balloon dilatation catheters.
Practical Guidance
How to identify if yours is affected
- Check UPNs M0062101180 and M0062101600 on your NephroMax Kit.
- Match device with Encore 26 Inflation Device in use.
- Review FDA recall page for official instructions.
Where to find product info
Official recall notice on FDA enforcement database and Boston Scientific communications.
What timeline to expect
Hospitals should contact Boston Scientific for replacement or corrective actions; timelines vary by facility.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Contact Boston Scientific regulatory affairs
- Report to CPSC if consumer devices are involved in non-clinical settings
How to prevent similar issues
- Establish device-tracking for high-risk catheter kits
- Verify supplier recalls before procedures
- Maintain updated recall contact list for medical suppliers
Documentation advice
Save all recall notices, correspondence, device serial numbers, and replacement acknowledgments
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Product Details
Product: Boston Scientific NephroMax Kit. UPNs: M0062101180; M0062101600. Category: Medical device. Stage: Recall active. Distribution: Worldwide. Quantity: 458 units. Affected area: Urology.
Reported Incidents
No specific incidents or injuries are cited in the provided recall notice.
Key Facts
- High safety risk for invasive device use
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Safety Guide
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