Reported Sep 17, 2025 · Ongoing
Boston Scientific UroMax Ultra Kit, Material Numbers (UPN)
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
Boston Scientific UroMax Ultra Kit, Material Numbers (UPN)
12 of 12 products
| Model / number | Product as published |
|---|---|
M0062251200 | Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. |
M0062251210 | 2. |
M0062251220 | 3. |
M0062251230 | 4. |
M0062251240 | 5. |
M0062251260 | 6. |
M0062251290 | 7. |
M0062251300 | 8. |
M0062251310. | 9. |
M0062251350 | 10. |
M0062251360 | 11. |
M0062251370. | 12. |
- Lot codes and dates
12 of 12 products
Products covered by this recall Model / number Product as published 8714729341277M0062251200, , Lot Numbers: 35536688, 35538633, 35538634, 35543803, 35543804, 35572728, 35678100 8714729341284M0062251210, , Lot Numbers: 35274797, 35274799, 35277223, 35277224, 35294475, 35294476, 35584203, 35584215, 35656798, 35667482, 35667483 8714729341291M0062251220, , Lot Numbers: 35257438, 35535450, 35536202, 35547680, 35656799 8714729341307M0062251230, , Lot Numbers: 35266389, 35543805 8714729341314M0062251240, , Lot Numbers: 35690647 8714729341338M0062251260, , Lot Numbers: 35537838, 35537839. 08714729341369M0062251290, , Lot Numbers: 35266391 08714729341376M0062251300, , Lot Numbers: 35275806, 35536992 08714729341383M0062251310, , Lot Numbers: 35536991 08714729341390M0062251350, , Lot Numbers: 35690648 08714729302421M0062251360, , Lot Numbers: 35257611, 35536990 08714729302438M0062251370, , Lot Numbers: 35294477, 35536689. - Amount recalled
- 1369 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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