Recall Z-2633-2026 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Boston Scientific Corporation
CRE Wireguided 8-10mm 240cm
| Date | Jul 1, 2026 (initiated May 21, 2026) |
| Status | Open, Classified |
| Reason | Potential sterile breach of the pouches in which devices are packaged. |
| Root cause | Package design/selection |
| Action | An Urgent Medical Device Removal - Immediate Action Required notification was mailed to consignees on 5/21/26. This notification informed consignees that Boston Scientific was conducting a removal of affected devices due to a potential sterile breach of product packaging (pouches). Consignees are instructed to immediately stop further use or distribution of product and quarantine them. Consignees are to complete and return the provided Reply Verification Tracking Form and return the product to Boston Scientific per the provided instructions. Consignees are to share the recall notification with |
| Quantity | 81,543 units |
| 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, Hun |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110833 | CRE BALLOON DILATATION CATHETER Boston Scientific Corporation, Apr 20, 2011 |