Boston Scientific Corporation: Stents, Drains And Dilators For The Biliary Ducts
Recall Summary Boston Scientific Corporation is recalling CRE Pro Wireguided 6-8mm 240cm biliary stents, drains, and dilators worldwide because the sterile packaging pouches may have been compromised. The devices were distributed across the United States, Canada, Australia, and numerous other countries. This is a Class II recall, meaning the devices could potentially cause serious health problems or failure, though injury or illness is not expected.
- Recalling firm
- Boston Scientific Corporation
- Product
- CRE Pro Wireguided 6-8mm 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/a490e234-2e34-4067-a24f-9f0dc83f01e5