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
December 4, 2024FDAAMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2OZ-0531-2025
December 4, 2024FDAAMS Artificial Urinary Sphincter Control PumpZ-0530-2025
November 20, 2024FDABoston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160Z-0302-2025
November 20, 2024FDABoston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CO…Z-0303-2025
November 20, 2024FDABoston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110Z-0301-2025
November 20, 2024FDABoston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100Z-0298-2025
November 20, 2024FDABoston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010Z-0299-2025
November 20, 2024FDABoston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.Z-0297-2025
November 20, 2024FDABoston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060Z-0300-2025
October 30, 2024FDABoston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 293…Z-0226-2025
October 23, 2024FDABoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST…Z-0101-2025
October 23, 2024FDABoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE…Z-0114-2025
October 23, 2024FDABoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST…Z-0097-2025
October 23, 2024FDABoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; t…Z-0104-2025
October 23, 2024FDABoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPG…Z-0110-2025
October 23, 2024FDABoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL EU + R…Z-0106-2025
October 23, 2024FDABoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN; the …Z-0099-2025
October 23, 2024FDABoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST…Z-0096-2025
October 23, 2024FDABoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the sys…Z-0109-2025
October 23, 2024FDABoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO…Z-0105-2025
October 23, 2024FDABoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the sys…Z-0100-2025
October 23, 2024FDABoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the …Z-0108-2025
October 23, 2024FDABoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST…Z-0103-2025
October 23, 2024FDABoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; th…Z-0107-2025
October 23, 2024FDABoston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE…Z-0115-2025

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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