FDA Device recall Z-2535-2025
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180
- FDA Device
- Class II
- ongoing
- Published 2025-09-17
On 2025-09-17 the FDA classified a Class II recall of Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180 by Boston Scientific, citing 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 determin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2535-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-05 |
| Published | 2025-09-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
Product
Boston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M0062101600. (Urology)
Reason
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.
Identifiers
| code_info | 1. M0062101180, GTIN 08714729077589, Lot Numbers: 35275630, 35603649, 35618255, 35644223, 35768091; 2. M0062101600, G…1. M0062101180, GTIN 08714729077589, Lot Numbers: 35275630, 35603649, 35618255, 35644223, 35768091; 2. M0062101600, GTIN 08714729834540, Lot Numbers: 35268077, 35294478, 35547681, 35576896, 35627459. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2535-2025%22
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