Boston Scientific UroMax Ultra Kit — Class II medical device recall Z-2536-2025
Ongoing recall by Boston Scientific Corporation, reported 2025-09-17. The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the b
| Recall number | Z-2536-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2025-08-05 |
| Classified | 2025-09-05 |
| Reported by FDA | 2025-09-17 |
| Quantity | 1,369 units |
| Reason classes | foreign material |
| UPC / GTIN / UDI-DI | 08714729302421, 08714729302438, 08714729341277, 08714729341284, 08714729341291, 08714729341307, 08714729341314, 08714729341338, 08714729341369, 08714729341376, 08714729341383, 08714729341390 |
| Lot numbers | 35257438, 35257611, 35266389, 35266391, 35274797, 35274799, 35275806, 35277223, 35277224, 35294475, 35294476, 35294477, 35535450, 35536202, 35536688, 35536689, 35536990, 35536991, 35536992, 35537838, 35537839, 35538633, 35538634, 35543803, 35543804, 35543805, 35547680, 35572728, 35584203, 35584215, 35656798, 35656799, 35667482, 35667483, 35678100, 35690647, 35690648, M0062251210, M0062251220, M0062251230 and 8 more |
Product
Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5. M0062251240, 6. M0062251260, 7. M0062251290, 8. M0062251300, 9. M0062251310. 10. M0062251350, 11. M0062251360, 12. M0062251370. (Urology)
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2536-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.