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.

Moderate

FDASep 9, 2025TN• NOXBOX LTD

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

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

Moderate

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

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.

Low

FDASep 9, 2025MI, TX• BioPro, Inc.

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

Undeclared Gluten

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

Class IHigh

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

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

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

Undeclared Allergen

Undeclared Yellow #5

Class IIModerate

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

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

Undeclared Allergen

Undeclared Yellow #5

Class IIModerate

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

ICU Medical Bag Spike (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

Rivian R1S (Rivian) – Hands-Free Highway Software (2025)

Rivian Automotive, LLC (Rivian) is recalling certain 2025 R1S and R1T vehicles operating a software version prior to 2025.18.30. The Hands-Free Highway Assist (HWA) software may fail to correctly identify a lead vehicle.

Moderate

NHTSASep 8, 2025Nationwide• RIVIAN

ICU Medical Oncology Kit (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ChemoLock Bag Spike (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical ChemosafeLock Connecter (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical ChemoLock Port (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

High

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical ChemoLock Vial Spike (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

High

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical Oncology Transfer Kit (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical Admin Set (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical Extension Set (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical ChemoLock Vial Spike (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Moderate

FDASep 8, 2025Nationwide• ICU Medical, Inc.

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