Boston Scientific Corporation: Medical Device Recall in 2025 - (Recall #: Z-2536-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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)

Product Classification:

Class II

Date Initiated: August 5, 2025

Date Posted: September 17, 2025

Recall Number: Z-2536-2025

Event ID: 97396

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.

Status: Ongoing

Product Quantity: 1369 units

Code Information:

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.

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated