Boston Scientific Corporation: Duodenoscope And Accessories, Flexible/rigid
Boston Scientific Corporation is recalling CRE Wireguided 10-12mm 240cm duodenoscopes and accessories due to potential breaks in the sterile packaging that could compromise the sterile barrier of the devices. The recall affects products distributed nationwide in the US and in numerous countries worldwide. This is a Class II recall, indicating a situation where use of the product could cause serious adverse health consequences or death.
- Recalling firm
- Boston Scientific Corporation
- Product
- CRE 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/545accdb-3ccc-4c45-87a8-e1e124b174fb