Boston Scientific Corporation: Duodenoscope And Accessories, Flexible/rigid
Boston Scientific is recalling CRE Wireguided 6-8mm 240cm duodenoscopes and accessories due to potential breaches in the sterile packaging that could compromise the devices' sterility. The recall affects units distributed nationwide in the US and in numerous countries worldwide. This is classified as a Class II recall.
- Recalling firm
- Boston Scientific Corporation
- Product
- CRE 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/65694650-2430-46ed-8286-d5b9e8d5e891