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Brand Name: Affixus Antegrade Femoral Nailing System Prod... (Zimmer, Inc.) – affected implants may have undersized... (2025)

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Moderate

FDADec 2, 2025Nationwide• Zimmer, Inc.

Wegmans Mixed Nuts (Mellace Brands) – Salmonella Risk (2025)

Salmonella

Potential contamination with Salmonella

Class IHigh

FDADec 2, 2025IN, NY, PA• Mellace Family Brands California Inc

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Brand Name: Affixus Antegrade Femoral Nailing System Prod... (Zimmer, Inc.) – affected implants may have undersized... (2025)

Wegmans Mixed Nuts (Mellace Brands) – Salmonella Risk (2025)

Ritz Peanut Butter Crackers (Mondelez) – Mispackaging (2025)

Cisatracurium Besylate Injection (Somerset) – Subpotent Product (2025)

Cisatracurium Besylate Injection (Somerset) – Subpotent Product (2025)

Rsch-Uchida Transjugular Liver Access Sets, Reference Par... (Cook Incorporated) – laceration hazard (2025)

Baclofen Tablets (Golden State) – Foreign Tablet Presence (2025)

Morphine Sulfate Solution (Winder) – Mispack Label Issue (2025)

Cisatracurium Besylate Injection (Somerset) – Subpotent Product (2025)

Flexor Check-Flo Introducers and Sets, Reference Part Num... (Cook Incorporated) – laceration hazard (2025)

Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A7... (Beckman Coulter, Inc.) – beckman coulter has determined that, ... (2025)

Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A7... (Beckman Coulter, Inc.) – beckman coulter has determined that, ... (2025)

Ring Transjugular Intrahepatic Access Sets, Reference Par... (Cook Incorporated) – laceration hazard (2025)

Brand Name: Mastisol Liquid Adhesive Product Name: Liquid... (Ferndale Laboratories, Inc.) – butyrate tube cracks during actuation... (2025)

Fat Free Milk (Prairie Farms) – cleaning agent contamination (2025)

Senna Leaf Herbal Tea (Celebration Herbals) – salmonella risk (2025)

Brand Name: Alcon Laboratories, Inc. Product Name: Custom... (Alcon Research LLC) – ophthalmic procedure packs may have i... (2025)

Duloxetine Capsules (Breckenridge) – Impurity Limit Exceeded (2025)

Zen Cleanse Herbal Tea (Bell Industries) – salmonella risk (2025)

Zimmer Dermatome AN, Model/Catalog Number: 88710100 (Zimmer Surgical Inc) – the devices may have a misaligned thi... (2025)