Reported Jul 8, 2026 · Ongoing
CRE Pro 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 Pro Wireguided 8-10mm 240cm
- Lot codes and dates
- UPNM00558670
- GTIN
92 of 92 codes
8714729797555Lot No. 3803149738031499380671063806710738067108380753523807769438078752380787533807875438078756381109823813154238131543381315443816287638169207381744333817672438176725381767283817672938200576382005773821206138240328382852243829743838297439382978003829780138306683383066843835796238357963383579643835796538357966383579673837155238381888383984933840016538437963384687573846875838468861385073063850730738552610385526113855261238552613385688653856886638568867385792823857928338591247
- 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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