Boston Scientific Corporation: Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific is recalling CRE Pro Wireguided biliary stents (8-10mm, 240cm) worldwide because the sterile packaging pouches may have been compromised during manufacturing. The affected devices were distributed across the United States and numerous countries including Canada, Europe, Asia, and Australia. This is a Class II recall, indicating a potential health risk if sterile barriers were breached.
- Recalling firm
- Boston Scientific Corporation
- Product
- CRE Pro Wireguided 8-10mm 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/4873244c-9339-4f22-a5ef-fe3646b7e95e