Boston Scientific Corporation: Duodenoscope And Accessories, Flexible/rigid
Recall Summary Boston Scientific is recalling CRE Wireguided duodenoscope accessories (15-18mm, 240cm) distributed worldwide because the sterile packaging pouches may have been breached. This is a Class II recall affecting medical facilities in the US and numerous countries internationally. The potential packaging breach could compromise the sterility of the devices.
- Recalling firm
- Boston Scientific Corporation
- Product
- CRE Wireguided 15-18mm 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/8bfa85d1-adeb-489e-93d3-ed26c878ad0d