Reported Jul 8, 2026 · Ongoing · Updated Sep 16, 2026
CRE Wireguided 10-12mm 240cm
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 · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- CRE Wireguided 10-12mm 240cm
- Lot codes and dates
- UPNM00558470
- GTIN
8714729339403Lot No. 38099718381650013816500238196568381965693819657038204511382045123820451338285933383977923839876738398768385073083855211538596881385968823861282938612830386800583868338438683385386894343869017138707829387078303871048038769697388001823880018338871161388711623887116338937571Exp. November 22028 February 232029
- Amount recalled
- 81,543 units
This recall covers 12 products
The agency filed one notice per product. You are reading one of them; the other 11 are below.
Where it was sold
- Nationwide
Why it was recalled
Potential sterile breach of the pouches in which devices are packaged.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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