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Consumer Product Recalls
127,244 recalls from the U.S. Consumer Product Safety Commission, newest first.
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number L110, ESSENTIO SR SL MRI Pacemaker
Hazard: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number L101, ESSENTIO DR SL Pacemaker
Hazard: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number L100, ESSENTIO SR SL Pacemaker
Hazard: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number L231, PROPONENT DR EL MRI Pacemaker
Hazard: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number L221 PROPONENT DR EL Pacemaker
Hazard: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number L211 PROPONENT DR SL MRI Pacemaker
Hazard: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number L210 PROPONENT SR SL Pacemaker
Hazard: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls Model Number L209 PROPONENT DR (VDD) SL Pacemaker
Hazard: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls PROPONENT DR SL (Model L201)
Hazard: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls PROPONENT SR SL (Model L200)
Hazard: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls ACCOLADE DR EL MRI (Model L331)
Hazard: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls ACCOLADE DR EL (Model L321)
Hazard: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls ACCOLADE DR SL MRI (Model L311)
Hazard: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls ACCOLADE SR SL MRI (Model L310)
Hazard: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls ACCOLADE DR SL (Model L301)
Hazard: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Boston Scientific Corporation recalls ACCOLADE SR SL (Model L300)
Hazard: Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls BRONCHOVIDEOSCOPE OLYMPUS BF-Q170
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.