Class IIOngoingZ-2632-2026
Boston Scientific Corporation recalls CRE Wireguided 6-8mm 240cm
Potential sterile breach of the pouches in which devices are packaged.
Boston Scientific Corp…MAJul 8, 2026
Recalls in Massachusetts
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 61–72 of 426 recalls
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
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 IOngoingZ-2605-2026
Insulet Corporation recalls Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack)
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery.…
Insulet CorporationMAJul 8, 2026
Class IOngoingZ-2604-2026
Insulet Corporation recalls Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack)
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery.…
Insulet CorporationMAJul 8, 2026
Class IOngoingZ-2603-2026
Insulet Corporation recalls Omnipod 5 Pods. Includes the below Model/REF Numbers: 1. POD-OMNI-I1-6720. 2. PO…
External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery.…
Insulet CorporationMAJul 8, 2026
Class IOngoingZ-2602-2026
Abiomed, Inc. recalls Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low…
Potential for thrombus formation during prolonged use of the introducer.
Abiomed, Inc.MAJul 1, 2026
Class IOngoingZ-2601-2026
Abiomed, Inc. recalls Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low…
Potential for thrombus formation during prolonged use of the introducer.
Abiomed, Inc.MAJul 1, 2026