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PERLA TL MIS Screw (SPINEART) – Incorrect Labeling (2025)

Cannulated fenestrated polyaxial screws may be incorrectly labeled

Moderate

FDAJun 30, 2025Nationwide• SPINEART SA Chemin Du Pre-Fleuri 3 Plan-Les-Ouates Switzerland

Ingenia Elition X (Philips) – Gradient Coil Failure (2025)

Fire/Burn Risk

The potential for component failures in the Gradient Coil of the affected MR systems may act as a heat source with a potential to produce smoke and/or fire.

High

FDAJun 30, 2025Nationwide• Philips North America

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PERLA TL MIS Screw (SPINEART) – Incorrect Labeling (2025)

Ingenia Elition X (Philips) – Gradient Coil Failure (2025)

Pro Spotter (TICO) – Non-DOT Brake Fitting (2025)

Achieva 3.0T (Philips) – Gradient Coil Failure (2025)

Duloxetine Capsules (Breckenridge) – CGMP Impurity (2025)

Budesonide Inhalation Suspension (Cipla) – Sterility Issue (2025)

Omeprazole Capsules (Dr. Reddy's) – Foreign Tablets (2025)

Ingenia 1.5T (Philips) – Gradient Coil Failure (2025)

DreamStation Auto BiPAP (Philips Respironics) – Configuration Error (2025)

Achieva XR (Philips) – Gradient Coil Failure (2025)

Fresh Sliced Mushrooms (Aunt Mid's) – Listeria Risk (2025)

Thick Slice Mushrooms (Peeters) – Listeria Risk (2025)

Cremini Sliced Mushrooms (Peeters) – Listeria Risk (2025)

Sprouted Moong (Deep) – Salmonella Contamination (2025)

Sprouted Mat (Deep) – Salmonella Contamination (2025)

Newmar Essex (NEWMAR) – Baggage Door Skin (2025)

Sprinter Cart Infusion Pole (Maquet) – Labeling Requirement (2025)

F-150 Lightning BEV (FORD) – Brake Hose Bracket (2025)

Cascadia Fifth Gen (FREIGHTLINER) – Fuel Line Risk (2025)

Accelera Omikron A/T Tire (ACCELERA) – Sidewall Separation (2025)