Reported Jul 8, 2026 · Ongoing · Updated Sep 16, 2026
CRE Pro Wireguided 10-12mm 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 10-12mm 240cm
- Lot codes and dates
- UPNM00558680
- GTIN
148 of 148 codes
8714729797562Lot No. 3803162038031621380316223803162338031624380316253803162638031627380316283803162938031631380753533807835738078358380783593807874038078741380787423807874338078744380787453807874738100058381007173810071838118422381184233811842438118425381184263811842738139132381391333816287738164341381692053816920638172338381767263817672738187282381872833819352138238865383040603830406138304062383040633830406438306688383340703833407138334072383340733838398638398490383984913839849238402798
- 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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