Boston Scientific Corporation 2026-07-08 Health serious FDA
Health · FDA · Recall #FDA-Z-2629-2026
CRE Pro Wireguided 12-15mm 240cm Recall
Issued July 8, 2026 · Boston Scientific Corporation
In July 2026, Boston Scientific Corporation recalled the CRE Pro Wireguided 12-15mm 240cm, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Dana Whitfield, RecallCheckr
What this means for you
Potential sterile breach of the pouches in which devices are packaged.
What you should do
- 1 Stop using CRE Pro Wireguided 12-15mm 240cm right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Boston Scientific Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Boston Scientific Corporation
- Category
- Health
- Recall date
- July 8, 2026
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China
- Recall number
- FDA-Z-2629-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Boston Scientific Corporation has 37 recalls in our database, including 13 rated Critical.
- We're tracking 3,673 Health recalls in our database.
- This is the 453rd Health recall we've logged in 2026.