Reported Jul 8, 2026 · Ongoing
CRE 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 Wireguided 12-15mm 240cm
- Lot codes and dates
- UPNM00558480
- GTIN
8714729339410Lot No. 3803356738056239380569403805694138215260382668543826685538293330383918813841387638413877384138783841387938414080384225473844620438466097384688623846886338529518385295193858500438622477386224783864099438670501386705023867050438686282386862833869372538726666387266673874825438767487387899963880018138879160388791633887916438911928389119293891193038944841Exp. October 242028 February 242029
- 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.