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Restore Clinician Programmer Application (CP App), Model ... (Medtronic Neuromodulation) – software issue where a device reset m... (2025)

Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.

Moderate

FDANov 20, 2025Nationwide• Medtronic Neuromodulation

Baby Soothe Herbal Supplement (A New Life Herbs) – misbranded (2025)

Unapproved drug claims on product labeling and product misbranded due to no Supplement Facts label

Class IIModerate

FDANov 20, 2025AL, AZ, CA +9 more• A New Life Herbs, LLC

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Restore Clinician Programmer Application (CP App), Model ... (Medtronic Neuromodulation) – software issue where a device reset m... (2025)

Baby Soothe Herbal Supplement (A New Life Herbs) – misbranded (2025)

Organic Ginger Root Supplement (A New Life Herbs) – misbranded (2025)

Tropicamide Ophthalmic Solution (Fagron) – Incorrect Formulation (2025)

BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation E... (CareFusion 303, Inc.) – automated dispensing cabinets (adc) r... (2025)

Anti-virus Herbal Supplement (A New Life Herbs) – misbranded (2025)

Boswellia Herbal Supplement (A New Life Herbs) – misbranded (2025)

Pain Away Herbal Supplement (A New Life Herbs) – misbranded (2025)

Aluminum Pot (Alanwar Food) – lead contamination (2025)

Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Ca... (Vortex Surgical Inc.) – reason for the voluntary recall is so... (2025)

Milk Pan (Shata Traders) – lead contamination (2025)

AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 705... (Steris Corporation) – wire connected to the electrical box ... (2025)

AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 70... (Steris Corporation) – wire connected to the electrical box ... (2025)

Puff Pastry (Karabetian Imports) – banned oils (2025)

Nebivolol Tablets (Glenmark) – Cross Contamination (2025)

Hardware configuration of the BeneVision Central Monitori... (Mindray DS USA, Inc. dba Mindray North America) – when the worstation of the benevision... (2025)

HemosIL SynthAFax. Partial Thromboplastin Time Tests. (Instrumentation Laboratory) – recalled lots were manufactured with ... (2025)

Intelerad InteleShare software, with ProViewer component (DICOM Grid, Inc.) – software intended to aid in diagnosin... (2025)

Kunefe (Karabetian Imports) – banned oils (2025)

Tater Gems (Simplot) – plastic fragments (2025)