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Showing 1121–1140 of 3001 results

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S'Mores Ooey Gooey Cookie (Toto Foods) – conflicting ingredient labels (2025)

Product label contains conflicting statements about inclusion and being free of Soy ingredient.

Class IIModerate

FDAAug 20, 2025AZ, CA, CO +11 more• Toto Foods, Inc.

Campsite Lentejas Soup (Itacate Foods) – undeclared food coloring (2025)

Undeclared Allergen

Undeclared Yellow #5 and Yellow #6.

Class IIModerate

FDAAug 20, 2025AK, AZ, CA +23 more• Itacate Foods LLC

Sulfamethoxazole Trimethoprim Tablets (Northwind Pharmaceuticals) - Foreign Substance (2025)

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDAAug 20, 2025Nationwide• Northwind Pharmaceuticals LLC

Charge-Up Chilaquiles (Itacate Foods) – undeclared food coloring (2025)

Undeclared Allergen

Undeclared Yellow #5 and Yellow #6.

Class IIModerate

FDAAug 20, 2025AK, AZ, CA +23 more• Itacate Foods LLC

ALTRUA 2 DR EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

ACCOLADE DR EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

Carvedilol Tablets (Harvard Drug Group) - Impurity Concern (2025)

CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

Class IIModerate

FDAAug 20, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

ESSENTIO SR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

ACCOLADE DR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

VISIONIST CRT-P EL MRI Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

Hostess Ding Dongs (Smucker's) – mold contamination (2025)

Mold. The firm noticed an increase in customer complaints. They conducted a root cause investigation and discovered that one of their coolers had malfunctioning.

Class IIModerate

FDAAug 20, 2025AL, AZ, AR +39 more• The J.M. Smucker Company

VALITUDE CRT-P EL MRI Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

ESSENTIO DR EL MRI Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

Impella Controller (Abiomed) – Pump Driver Circuit Issue (2025)

Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.

FDAAug 20, 2025AZ, AR, CA +14 more• Abiomed, Inc.

ACCOLADE SR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

PROPONENT SR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

PROPONENT DR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

ALTRUA 2 DR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

ALTRUA 2 SR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

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).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

Acetaminophen Injection (Baxter Healthcare) - Discoloration (2025)

Discoloration

Class IIModerate

FDAAug 20, 2025Nationwide• Baxter Healthcare Corporation

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