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
September 23, 2026FDABoston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) …Z-3188-2026
September 9, 2026FDALUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS…Z-3082-2026
September 9, 2026FDALUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS…Z-3083-2026
September 9, 2026FDALUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS…Z-3081-2026
August 26, 2026FDABoston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-2…Z-2978-2026
August 26, 2026FDAOverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.Z-2961-2026
August 26, 2026FDASuture Cinch Long 1pk. Endoscopic tissue approximation device.Z-2962-2026
August 26, 2026FDABoston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NP…Z-2977-2026
August 12, 2026FDARadial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Ja…Z-2840-2026
August 12, 2026FDARadial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: …Z-2838-2026
August 12, 2026FDARadial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1.…Z-2839-2026
July 29, 2026FDAFARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percu…Z-2750-2026
July 29, 2026FDAFARADRIVE STEERABLE SHEATH CLEAR, used to facilitate access to the vasculature and into t…Z-2755-2026
July 29, 2026FDAFARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percu…Z-2753-2026
July 29, 2026FDABoston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Ra…Z-2771-2026
July 29, 2026FDAFARADRIVE STEERABLE SHEATH CLEAR OUS, used to facilitate access to the vasculature and in…Z-2757-2026
July 29, 2026FDAFARADRIVE STEERABLE SHEATH (CLEAR) - US, used to facilitate access to the vasculature and…Z-2756-2026
July 29, 2026FDAFARASTAR PFA Generator, Product ID M004PFCE61M460; Percutaneous Cardiac Ablation CatheterZ-2752-2026
July 29, 2026FDAFARASTAR Pulsed Field Ablation Generator, Product ID M004PFCE61M401; Percutaneous Cardiac…Z-2751-2026
July 29, 2026FDAFARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and in…Z-2754-2026
July 22, 2026FDARapid Refill Continuous Injection System, UPN M00566001Z-2725-2026
July 8, 2026FDACRE Pro Wireguided 12-15mm 240cmZ-2629-2026
July 8, 2026FDACRE Pro Wireguided 18-20mm 240cmZ-2631-2026
July 8, 2026FDACRE Wireguided 15-18mm 240cmZ-2636-2026
July 8, 2026FDACRE Wireguided 6-8mm 240cmZ-2632-2026

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.
What was the most recent Boston Scientific Corporation recall?
FDA recall Z-3188-2026, published September 23, 2026: Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable REF: M0067933000, M006793300H0, M00…
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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