Boston Scientific Corporation: Duodenoscope And Accessories, Flexible/rigid
Recall Summary Boston Scientific is recalling CRE Wireguided 8-10mm 240cm duodenoscopes and accessories worldwide because the sterile packaging pouches may have been breached. The devices were distributed across the United States, Canada, and numerous other countries. This is classified as a Class II recall, meaning the devices could potentially cause harm but serious injury or death is not likely.
- Recalling firm
- Boston Scientific Corporation
- Product
- CRE 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/48649c2b-14cc-49a0-9a10-04fdd0f63b54