Reported Jul 8, 2026 · Ongoing · Updated Sep 16, 2026
CRE Pro Wireguided 6-8mm 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 6-8mm 240cm
- Lot codes and dates
- UPNM00558660
- GTIN
8714729797548Lot No. 380314923803149338031494380753513807875838078759381305993813154038131541381628783818728438187285382046943820469538204696383802123838033338408115384081163840811738408118386080973862222138642730386783133869356938770151387701523886460738864608389060293893394938960096Exp. November 232028 March 292029
- 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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