Class IIOngoingZ-2631-2026
Boston Scientific Corporation recalls CRE Pro Wireguided 18-20mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Boston Scientific Corp…MAJul 8, 2026
Stents, Drains And Dilators For The Biliary Ducts recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–8 of 8 recalls
Class IIOngoingZ-2630-2026
Boston Scientific Corporation recalls CRE Pro Wireguided 15-18mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Boston Scientific Corp…MAJul 8, 2026
Class IIOngoingZ-2629-2026
Boston Scientific Corporation recalls CRE Pro Wireguided 12-15mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Boston Scientific Corp…MAJul 8, 2026
Class IIOngoingZ-2628-2026
Boston Scientific Corporation recalls CRE Pro Wireguided 10-12mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Boston Scientific Corp…MAJul 8, 2026
Class IIOngoingZ-2627-2026
Boston Scientific Corporation recalls CRE Pro Wireguided 8-10mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Boston Scientific Corp…MAJul 8, 2026
Class IIOngoingZ-2626-2026
Boston Scientific Corporation recalls CRE Pro Wireguided 6-8mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Boston Scientific Corp…MAJul 8, 2026
Class IIOngoingZ-1786-2026
Cook Incorporated recalls COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS…
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Cook IncorporatedINApr 15, 2026
Class IIOngoingZ-2618-2025
Boston Scientific Corporation recalls Extractor Pro RX Retrieval Balloon Catheter
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
Boston Scientific Corp…MAOct 1, 2025