Boston Scientific Corporation: 296 recalls on record

Recalls filed with 1 agency: FDA (296).

First recall on record: June 27, 2012. Most recent: September 23, 2026.

Risk classification: Class I: 73 · Class II: 221 · Class III: 2

Most recent recalls

DateAgencyProduct
July 8, 2026FDACRE Pro Wireguided 15-18mm 240cmZ-2630-2026
July 8, 2026FDACRE Pro Wireguided 6-8mm 240cmZ-2626-2026
July 8, 2026FDACRE Wireguided 10-12mm 240cmZ-2634-2026
July 8, 2026FDACRE Pro Wireguided 8-10mm 240cmZ-2627-2026
July 8, 2026FDACRE Wireguided 8-10mm 240cmZ-2633-2026
July 8, 2026FDACRE Pro Wireguided 10-12mm 240cmZ-2628-2026
July 8, 2026FDACRE Wireguided 12-15mm 240cmZ-2635-2026
July 8, 2026FDACRE Wireguided 18-20mm 240cmZ-2637-2026
July 1, 2026FDAIntera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug deli…Z-2580-2026
June 17, 2026FDAOrca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca …Z-2413-2026
May 13, 2026FDALUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON …Z-2049-2026
May 13, 2026FDALUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, M…Z-2048-2026
May 6, 2026FDABoston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P…Z-1771-2026
May 6, 2026FDABoston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Sync…Z-1770-2026
October 22, 2025FDAModel Number L231, PROPONENT DR EL MRI PacemakerZ-0091-2026
October 22, 2025FDAModel Number L211 PROPONENT DR SL MRI PacemakerZ-0089-2026
October 22, 2025FDAModel Number L101, ESSENTIO DR SL PacemakerZ-0093-2026
October 22, 2025FDAModel Number S702, ALTRUA 2 DR SL PacemakerZ-0099-2026
October 22, 2025FDATENACIO Pump without InhibiZone; UPN: 72404420;Z-0139-2026
October 22, 2025FDAModel Number U128, VALITUDE CRT-P EL MRIZ-0102-2026
September 17, 2025FDABoston Scientific NephroMax Kit, Material Numbers (UPN): 1. M0062101180; 2. M006210…Z-2535-2025
September 10, 2025FDAWATCHMAN FXD Curve Access System Dbl, US, Material Number (UPN) M635TU80020; intended to …Z-2435-2025
May 7, 2025FDAIceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are in…Z-1687-2025
February 5, 2025FDAAXIOS Stent and Delivery System 10mmx10mm UPN: M00553740Z-1030-2025
January 22, 2025FDAPROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Mod…Z-0823-2025

Questions about this company

How many recalls does Boston Scientific Corporation have?
Recalert has 296 U.S. recalls on record for Boston Scientific Corporation, published between June 27, 2012 and September 23, 2026.
Which agencies have handled Boston Scientific Corporation recalls?
Boston Scientific Corporation appears as the recalling firm in recalls from: FDA (296).

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