FDA Medical devices recall ·
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180 recall
- Recall number
- Z-2535-2025
- Date
- (initiated August 5, 2025)
- Company / brand
- Boston Scientific Corporation
1 Scimed Pl, Maple Grove, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 458 units
- Hazard tags
- Foreign material
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1. M0062101180, GTIN 08714729077589, Lot Numbers: 35275630, 35603649, 35618255, 35644223, 35768091; 2. M0062101600, GTIN 08714729834540, Lot Numbers: 35268077, 35294478, 35547681, 35576896, 35627459.
Distribution
Worldwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2535-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.