Reported Jul 8, 2026 · Ongoing
CRE Pro 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 Pro Wireguided 15-18mm 240cm
- Lot codes and dates
- UPNM00558700
- GTIN
166 of 166 codes
8714729797586Lot No. 3804311638192116381921173819211838192119381929603819296138214896382148973822215338222496382224973822249838222499382226603822266138222662382226633822266438222665382388643823908438239085382390863823908738239088382390893824187438241875382418763824267938242820382428213824282238242824382691343826913538274558382745593828241238324631383246323832463338324634383246363832463738324638383473253834732638347327383473283836430038381887384219063842190738421908384219093842191038421911
- 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.
Free recall alerts
Get alerted about new Boston Scientific Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.