Boston Scientific Corporation: Duodenoscope And Accessories, Flexible/rigid
Recall Summary Boston Scientific is recalling CRE Wireguided 12-15mm 240cm duodenoscopes and accessories distributed worldwide because the sterile packaging pouches may have been compromised. This Class II recall affects devices distributed across the US, Canada, Australia, and numerous other countries. The affected devices were used for medical procedures and may not have maintained their sterile condition.
- Recalling firm
- Boston Scientific Corporation
- Product
- CRE Wireguided 12-15mm 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/34f250e7-338f-4866-af92-9351cab0eeff