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).

Moderate

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.

High

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

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

Moderate

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

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

Moderate

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

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

Moderate

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

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

Moderate

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

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

Moderate

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

Lemon Meringue Pie (Jessie Lord Bakery) – undeclared food coloring (2025)

Undeclared Allergen

Undeclared Yellow#5 in Lemon Meringue Pie

Class IIModerate

FDAAug 20, 2025AL, AZ, CA +11 more• Jessie Lord Bakery, LLC

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

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

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

Moderate

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

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

Moderate

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

Vacuette Serum Separator (Greiner Bio-One) – Missing Gel Separator (2025)

Some of the Vacuette CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require the patient to return to the lab for recollection or repeat testing. This may result in delayed diagnosis, cause a delay in clinical decision-making or treatment and in some rare cases, yield incorrect results from less stable parameters.

Moderate

FDAAug 19, 2025AL, AR, CA +25 more• Greiner Bio-One North America, Inc.

Sand Bar Frozen Shrimp (Southwind Foods) – cesium contamination (2025)

Product manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137)

Class IIModerate

FDAAug 19, 2025AL, AZ, CA +6 more• Southwind Foods LLC dba Great American Seafood Imports Co.

Green Mint Chip Ice Cream (Hershey Creamery) – elevated coliform (2025)

Product tested elevated coliform counts during routine testing

Class IIModerate

FDAAug 19, 2025DE, FL, IN +4 more• HERSHEY CREAMERY CO.

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