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Showing 1321–1340 of 4423 results

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Der Mutterschaf Cheese (Goot Essa) – Listeria Contamination (2025)

The firm had a positive Listeria Monocytogenes on a sample from this batch of product made.

FDASep 10, 2025CT, MT, NJ +1 more• GOOT ESSA, LLC

TactiFlex Ablation Catheter (Abbott) – Tip Detachment Risk (2025)

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

FDASep 10, 2025Nationwide• Abbott

Vanilla Apricot Jam Cookies (Gina Marie Bakery) – Undeclared Colors (2025)

Undeclared Allergen

Undeclared Red 40 and Yellow 6

Class IIModerate

FDASep 10, 2025CT• Gina Marie Bakery LLC

Italian Sesame Cookies (Gina Marie Bakery) – Undeclared Allergens (2025)

Undeclared Allergen

Undeclared Sesame, Undeclared Yellow 5, Red 40, Yellow 6

Class IIModerate

FDASep 10, 2025CT• Gina Marie Bakery LLC

Vanilla Chocolate Dipped Cookies (Gina Marie Bakery) – Undeclared Red 40 (2025)

Undeclared Allergen

Undeclared Red 40

FDASep 10, 2025CT• Gina Marie Bakery LLC

Toasted Cherry Biscotti (Gina Marie Bakery) – Undeclared Red 40 (2025)

Undeclared Allergen

Contains undeclared Red 40

FDASep 10, 2025CT• Gina Marie Bakery LLC

Goodles Truffle Cheddar Shells (Gooder Foods) – Undeclared Cashews (2025)

Undeclared Allergen

Undeclared allergens (cashews).

FDASep 10, 2025AL, AZ, AR +34 more• Gooder Foods, Inc.

Italian Mixed Vanilla Cookies (Gina Marie Bakery) – Undeclared Allergens (2025)

Undeclared Allergen

Undeclared Almonds, Sesame, Red 40, Red 3, and Blue 1

Class IIModerate

FDASep 10, 2025CT• Gina Marie Bakery LLC

Toasted Almond & Cherry Biscotti (Gina Marie Bakery) – Undeclared Red 40 (2025)

Undeclared Allergen

Undeclared Red 40

FDASep 10, 2025CT• Gina Marie Bakery LLC

Zero DS (Zero) – Wiring Routing Problem (2024)

Zero Motorcycles Inc. (Zero) is recalling certain 2023-2024 DSR/X, 2024 DS, DSR, and DSRP motorcycles. Improperly routed key switch signal wires may break, causing a loss of drive power.

NHTSASep 9, 2025Nationwide• ZERO

Mint Flavored Tablets (Eskay Brands) – Undeclared Yellow #5 (2025)

Undeclared Allergen

Undeclared Yellow #5

Class IIModerate

FDASep 9, 2025IN, TX• Eden¿¿¿s Elixirs, LLC

Fresh Basil Olive Oil (Lotsa Pasta) – Botulinum Contamination (2025)

Potential to be contaminated with Clostridium botulinum. Products manufactured without an approved process filed.

Class IIModerate

FDASep 9, 2025KY• Hale inc

Blueberry Almond Granola (Whole Foods Market) – Mislabeled Allergens (2025)

Undeclared Gluten

Product was incorrectly labeled, resulting in undeclared wheat, sesame, and cashew.

FDASep 9, 2025IN, PA• WFM Purchasing, LP

BioPro Femoral Head (BioPro) – Sterile Packaging Issue (2025)

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

FDASep 9, 2025MI, TX• BioPro, Inc.

Ashvins HEYEX 2 (MedicalCommunications) – Measurement Inaccuracy (2025)

Potential that the measured value may be smaller than the actual area.

FDASep 9, 2025Nationwide• MedicalCommunications GmbH Max-Jarecki-Str. 8 Heidelberg Germany

NOxBOXi Nitric Oxide System (NOXBOX) – Internal Fault Risk (2025)

The unexpected internal fault / system diagnostic error to result when a rapid succession of button selections is made to the user interface without waiting for the device to respond to user prompts.

FDASep 9, 2025TN• NOXBOX LTD

Mint Flavored Tablets (Lifted Made) – Undeclared Yellow #5 (2025)

Undeclared Allergen

Undeclared Yellow #5

Class IIModerate

FDASep 9, 2025IN, TX• Eden¿¿¿s Elixirs, LLC

Roasted Garlic Olive Oil (Lotsa Pasta) – Botulinum Contamination (2025)

Potential to be contaminated with Clostridium botulinum. Products manufactured without an approved process filed.

Class IIModerate

FDASep 9, 2025KY• Hale inc

Lifted Made-Lemon Tablet (Eden's Elixirs) – Undeclared Yellow #5 (2025)

Undeclared Allergen

Undeclared Yellow #5

Class IIModerate

FDASep 9, 2025IN, TX• Eden¿¿¿s Elixirs, LLC

BioPro Femoral Head (BioPro) – Sterile Packaging Issue (2025)

Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

FDASep 9, 2025MI, TX• BioPro, Inc.

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