Reported Jul 8, 2026 · Ongoing
CRE Pro Wireguided 12-15mm 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 12-15mm 240cm
- Lot codes and dates
- UPNM00558690
- GTIN
173 of 173 codes
8714729797579Lot No. 3803163538031636380316373803163838031639380316403803164138043114380431153805361438053615380536163807835438188253382005783821178038214898382148993822248538222487382418713824187238267022382670233826702438267025382670263826702738267028382691363826913738269138382777543827775538278152382781533827815438285222382852233829332238293324382933253829332638293327382933283829332938303877383038783832046338346663383466643834668138347329383783763837927338379917383799183837991938380040
- 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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