FDA Class II · Medical device · July 8, 2026
CRE Wireguided 18-20mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2637-2026 · Official record ↗
Boston Scientific recalls
18 recent recalls on record for Boston Scientific in CPSC, NHTSA, and FDA data as of July 24, 2026 at 1:09 AM UTC.
Models with recalls
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as (1)Boston Scientific Pacemaker (1)CRE Pro Wireguided 10-12mm 240cm (1)CRE Pro Wireguided 12-15mm 240cm (1)CRE Pro Wireguided 15-18mm 240cm (1)CRE Pro Wireguided 18-20mm 240cm (1)CRE Pro Wireguided 6-8mm 240cm (1)CRE Pro Wireguided 8-10mm 240cm (1)CRE Wireguided 10-12mm 240cm (1)CRE Wireguided 12-15mm 240cm (1)CRE Wireguided 15-18mm 240cm (1)CRE Wireguided 18-20mm 240cm (1)CRE Wireguided 6-8mm 240cm (1)CRE Wireguided 8-10mm 240cm (1)Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump (1)LUX-DX II (1)LUX-Dx II Plus (1)Orca Single Use Air/Water and Suction Valves (1)
All Boston Scientific recalls
FDA Class II · Medical device · July 8, 2026
CRE Wireguided 15-18mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2636-2026 · Official record ↗
FDA Class II · Medical device · July 8, 2026
CRE Wireguided 12-15mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2635-2026 · Official record ↗
FDA Class II · Medical device · July 8, 2026
CRE Wireguided 10-12mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2634-2026 · Official record ↗
FDA Class II · Medical device · July 8, 2026
CRE Wireguided 8-10mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2633-2026 · Official record ↗
FDA Class II · Medical device · July 8, 2026
CRE Wireguided 6-8mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2632-2026 · Official record ↗
FDA Class II · Medical device · July 8, 2026
CRE Pro Wireguided 18-20mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2631-2026 · Official record ↗
FDA Class II · Medical device · July 8, 2026
CRE Pro Wireguided 15-18mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2630-2026 · Official record ↗
FDA Class II · Medical device · July 8, 2026
CRE Pro Wireguided 12-15mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2629-2026 · Official record ↗
FDA Class II · Medical device · July 8, 2026
CRE Pro Wireguided 10-12mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2628-2026 · Official record ↗
FDA Class II · Medical device · July 8, 2026
CRE Pro Wireguided 8-10mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2627-2026 · Official record ↗
FDA Class II · Medical device · July 8, 2026
CRE Pro Wireguided 6-8mm 240cm recall — Boston Scientific Corporation
Potential sterile breach of the pouches in which devices are packaged.
Official ID Z-2626-2026 · Official record ↗
FDA Class II · Medical device · July 1, 2026
Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump recall — Boston Scientific Corporation
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
Official ID Z-2580-2026 · Official record ↗
FDA Class II · Medical device · June 17, 2026
Orca Single Use Air/Water and Suction Valves recall — Boston Scientific Corporation
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button …
Official ID Z-2413-2026 · Official record ↗
FDA Class II · Medical device · May 13, 2026
LUX-Dx II Plus recall — Boston Scientific Corporation
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhy…
Official ID Z-2049-2026 · Official record ↗
FDA Class II · Medical device · May 13, 2026
LUX-DX II recall — Boston Scientific Corporation
For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhy…
Official ID Z-2048-2026 · Official record ↗
FDA Class I · Medical device · May 6, 2026
Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as recall — Boston Scientific Corporation
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 an…
Official ID Z-1771-2026 · Official record ↗
FDA Class I · Medical device · May 6, 2026
Boston Scientific Pacemaker recall — Boston Scientific Corporation
Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 an…
Official ID Z-1770-2026 · Official record ↗
Verify with the official sources:
- CPSC — consumer products ↗ (aggregated here)
- NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
- FDA — food, drugs, medical devices ↗ (aggregated here)
- USDA FSIS — meat, poultry & egg products ↗ (not yet aggregated here)
- Recalls.gov — the U.S. government’s all-agency portal ↗
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Compiled from official public-domain government data. Last checked July 24, 2026 at 1:09 AM UTC.