Safety Alert: Class II: 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.
healthelectronicsClass IIRecalled on Sep 17, 2025
Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5. M0062251240
🔢 1369 units
Sold At: Boston Scientific Corporation(Worldwide distribution.)
Recall #: FDA-DEVICE-Z-2536-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- 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.
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Summary
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 next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Boston Scientific Corporation for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.