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Kunefe (Karabetian Imports) – banned oils (2025)

partially hydrogenated oils (PHOs) in foods exported to the US

FDANov 18, 2025AZ, CA, CO +8 more• Karabetian Import and Distribution, Inc.

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

Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare viewer; Multiplanar reconstruction applied; Manual rotation applied, could result in inaccurate length measurement tool values that could compromise diagnostic accuracy, lead to misdiagnosis or inappropriate follow-up.

High

FDANov 18, 2025AL, AK, AZ +42 more• DICOM Grid, Inc.

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Kunefe (Karabetian Imports) – banned oils (2025)

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

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

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

Ondansetron ODT Tablets (Preferred) – Defective Packaging (2025)

Triple E Unity (Triple E) – Incorrect Weight Label (2026)

Ford E-450 (Ford) – Engine Software (2025)

Peterbilt 567 (Peterbilt) – Brake Air Tanks (2025)

Hyundai IONIQ 5 (Hyundai) – Seat Belt Retractors (2025)

Thor Motor Coach Rize (Thor Motor Coach) – Critical Fastener Problem (2023)

Thor Motor Coach Twist (Thor) – Solar Panel Issue (2025)

Orthofix NorthStar OCT Navigation Surgical Technique Guid... (SEASPINE ORTHOPEDICS CORPORATION) – the northstar oct navigation surgical... (2025)

Kia K5 (Kia) – Fuel System Air Valve Defect (2021)

Sheathes3D Seamless Viral Barrier, Latex-Free, 7/8"D Tape... (Sheathing Technologies Inc) – vaginal/rectal ultrasound probe cover... (2025)

The Pressio 2 ICP Monitoring System, Model Number PSO-400... (Sophysa Rue Sophie Germain Besancon France) – customer complaints of pressio monito... (2025)

Hyundai Sonata (Hyundai) – Fuel System (2025)

Lava Bun Green Tea (Prime Food Processing) – undeclared milk (2025)

Lava Bun Salted Egg Yolk (Prime Food Processing) – undeclared milk (2025)

Charlevoix Mild Cheddar Cheese (Boss Dairy Farms) – Listeria risk (2025)

Halyard, MAJOR PACK. Catalog Number: JEMJ10-01. (AVID Medical, Inc.) – potential for incomplete seal on head... (2025)