Boston Scientific Corporation: Stents, Drains And Dilators For The Biliary Ducts
Recall Summary Boston Scientific Corporation is recalling CRE Pro Wireguided 10-12mm 240cm biliary stents, drains, and dilators due to potential sterile breaches in their packaging pouches. The affected devices were distributed worldwide, including throughout the United States and 50+ other countries. This is classified as a Class II recall.
- Recalling firm
- Boston Scientific Corporation
- Product
- CRE Pro Wireguided 10-12mm 240cm
- Reason
- Potential sterile breach of the pouches in which devices are packaged.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-21
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/da7f7083-d8da-4e36-947b-b2c70f374c3c