FDAFDA · Food and drugs·Recall number Z-2535-2025
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Published September 17, 2025 · Recall initiated: August 5, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- Worldwide distribution.
- Lot
- 1. M0062101180, GTIN 08714729077589, Lot Numbers: 35275630, 35603649, 35618255, 35644223, 35768091; 2. M0062101600, GTIN 08714729834540, Lot Numbers: 35268077, 35294478, 35547681, 35576896, 35627459.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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