Boston Scientific Corporation: Duodenoscope And Accessories, Flexible/rigid
Recall Summary Boston Scientific Corporation is recalling CRE Wireguided 18-20mm 240cm duodenoscopes and accessories due to potential sterile breaches in their packaging pouches. The affected devices were distributed worldwide, including across all US states and territories, plus numerous countries in Europe, Asia, the Middle East, Africa, and the Americas. This is a Class II recall, meaning the devices could cause serious adverse health effects or death.
- Recalling firm
- Boston Scientific Corporation
- Product
- CRE Wireguided 18-20mm 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/46378b6c-3dca-42dc-87b0-d4c4252d7350