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Halved Pears (Pacific Coast) – Lead Contamination (2025)

Potential contamination with heavy metal (Lead).

FDASep 4, 2025AL, AZ, AR +24 more• Pacific Coast Producers

Medical Convenience Kit (American Contract Systems) – Sterilization Error (2025)

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

Moderate

FDASep 4, 2025Nationwide• American Contract Systems Inc.

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Halved Pears (Pacific Coast) – Lead Contamination (2025)

Medical Convenience Kit (American Contract Systems) – Sterilization Error (2025)

Entecavir Tablets 0.5mg (Zydus) – impurity specification failure (2025)

FemiClear Daily Bladder Strength (Organicare) – Microbial Contamination (2025)

Subaru Solterra (Subaru) – HVAC System Defect (2024)

Medical Convenience Kit (American Contract Systems) – Sterilization Error (2025)

Jeep Wagoneer S (Jeep) – Transmission Park Spring (2025)

Neuroguard Carotid Stent (Contego Medical) – Embolic Protection Issue (2025)

Jayco Fifth Wheel Seismic (Jayco) – Incorrect Label (2026)

Jeep Wagoneer S (Jeep) – Cross Car Beam Issue (2025)

IC Bus CESB (IC Bus) – Underfloor Reinforcement (2020)

Medical Convenience Kit (American Contract Systems) – Sterilization Error (2025)

Cruiser Avenir (Cruiser) – Axle Clearance Issue (2025)

XERF EFFECTOR 60 (Lutronic) – Manufacturing Defects (2025)

Basic Biopsy Tray (American Contract Systems) – Sterilization Error (2025)

Baby Loungers (URMYWO) – Suffocation Risk (2025)

Cordless Grease Guns (Makita) – Laceration Hazard (2025)

AR-15 Chamber Lock Pro (StopBox USA) – Serious Injury Risk (2025)

Jeep Grand Cherokee (Jeep) – Hybrid System Error (2022)

Allura Xper CV20 (Philips) – Battery Depletion Risk (2025)