Boston Scientific Corporation: Stents, Drains And Dilators For The Biliary Ducts
Recall Summary Boston Scientific is recalling CRE Pro Wireguided biliary stents (15-18mm, 240cm) worldwide because the sterile packaging pouches may have been breached. This Class II recall affects devices distributed across the United States, Canada, Australia, and numerous other countries. The breach could potentially compromise the sterility of the devices.
- Recalling firm
- Boston Scientific Corporation
- Product
- CRE Pro Wireguided 15-18mm 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/85f7a303-94ab-4838-b01d-abf7024bad6e