Reported Jul 8, 2026 · Ongoing · Updated Sep 16, 2026
CRE Wireguided 18-20mm 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 18-20mm 240cm
- Lot codes and dates
- UPNM00558500
- GTIN
8714729339434Lot No. 38033572380632503806325138063252382117833821178438215261382152623821526338222236382222373822223838222239382418793824236038242361383340623833406338347338384688643847236438472365384797553859673338596734385967353859673638596883385968843869252638707831387097383870973938748244388088963887431238874313388743143888624838886249Exp. October 242028 February 172029
- 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.
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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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