Boston Scientific Corporation — Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5. M0062251240, 6. M0062251260,
⚠️ 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.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- August 5, 2025
Worldwide distribution.
What's affected?
- 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)
- Lot code
- 35536688
Additional details
1. M0062251200, GTIN 8714729341277, Lot Numbers: 35536688, 35538633, 35538634, 35543803, 35543804, 35572728, 35678100; 2. M0062251210, GTIN 8714729341284, Lot Numbers: 35274797, 35274799, 35277223, 35277224, 35294475, 35294476, 35584203, 35584215, 35656798, 35667482, 35667483; 3. M0062251220, GTIN 8714729341291, Lot Numbers: 35257438, 35535450, 35536202, 35547680, 35656799; 4. M0062251230, GTIN 8714729341307, Lot Numbers: 35266389, 35543805; 5. M0062251240, GTIN 8714729341314, Lot Numbers: 35690647; 6. M0062251260, GTIN 8714729341338, Lot Numbers: 35537838, 35537839. 7. M0062251290, GTIN 08714729341369, Lot Numbers: 35266391; 8. M0062251300, GTIN 08714729341376, Lot Numbers: 35275806, 35536992; 9. M0062251310, GTIN 08714729341383, Lot Numbers: 35536991; 10. M0062251350, GTIN 08714729341390, Lot Numbers: 35690648; 11. M0062251360, GTIN 08714729302421, Lot Numbers: 35257611, 35536990; 12. M0062251370, GTIN 08714729302438, Lot Numbers: 35294477, 35536689.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1369 units.
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