Reported Jul 8, 2026 · Ongoing
CRE Wireguided 8-10mm 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 8-10mm 240cm
- Lot codes and dates
- UPNM00558460
- GTIN
8714729339397Lot No. 3806405538099717381000333810003438164759381650003816500338293337382933383829333938333957383473353834733638398764383987653839876638529517385521123855211338596880386800563868005738739675Exp. October 272028 January 312029
- 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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