Reported Jul 8, 2026 · Ongoing · Updated Sep 16, 2026
CRE Wireguided 15-18mm 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 15-18mm 240cm
- Lot codes and dates
- UPNM00558490
- GTIN
8714729339427Lot No. 380335683803356938033570380335713804749838047722380477313820016738239090383250153832501638325017384132053841320638413207384132083841321438422540384225413842254238422543384797593850730338507304385194973851949838529540385295413852954238529543385295443858500538585006386477713879007938817673388176743881767538817676388176773881767838817679Exp. October 242028 February 92029
- 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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