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Testosterone Triamcinolone Pellet (Farmakeio) – metal particulate risk (2025)

CGMP Deviations: Potential presence of metal particulate matter

Class IIModerate

FDAOct 14, 2025Nationwide• FARMAKEIO OUTSOURCING LLC

Testosterone Triamcinolone Pellet (Farmakeio) – Metal Contamination (2025)

CGMP Deviations: Potential presence of metal particulate matter

Class IIModerate

FDAOct 14, 2025Nationwide• FARMAKEIO OUTSOURCING LLC

Nitto Trail Grappler Tire (Nitto) – Tire Tread Defect (2025)

Toyo Tire Holdings of Americas, Inc. (Toyo) is recalling certain Open Country A/T III, Open Country R/T Trail, Open Country M/T, Open Country H/T II, Crosstek 2, Dura Grappler Highway Terrain, Exo Grappler AWT, Mud Grappler Extreme Terrain, Recon Grappler A/T, Ridge Grappler, Terra Grappler G3 A/T, and Trail Grappler M/T tires. Please see the attached tire chart for all affected sizes. Contamination during production may reduce adhesion and cause the tread to separate.

Moderate

NHTSAOct 13, 2025Nationwide• NITTO

TMJ Bilateral Implant (TMJ Solutions) – Screw Hole Discrepancy (2025)

Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.

Moderate

FDAOct 13, 2025Nationwide• TMJ Solutions Inc

Phantom Fibula Nail (Paragon 28) – Thread Depth Specification (2025)

Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted.

Moderate

FDAOct 13, 2025Nationwide• Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062

DermaSensor (DermaSensor) – Result Specification Risk (2025)

Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.

Moderate

FDAOct 13, 2025AZ, CA, CT +5 more• DERMASENSOR INC

Amoxicillin Clavulanate Suspension (Teva) – subpotent drug (2025)

Subpotent drug; Clavulanate Potassium component

Class IIModerate

FDAOct 13, 2025CA, IN, MS +1 more• Teva Pharmaceuticals USA, Inc

Lincoln MKT (Lincoln) – Camera Sensing Failure (2025)

Ford Motor Company (Ford) is recalling certain 2015-2019 Flex, 2015 Explorer, Lincoln MKT, Lincoln MKZ, 2015-2016 C-Max, Escape, Taurus, 2016 Fusion, 2018-2019 Taurus, 2019 Lincoln MKT, Fiesta, and 2020 Mustang vehicles. The rearview camera may display a distorted, intermittent, or blank image when the vehicle is in reverse.

Moderate

NHTSAOct 13, 2025Nationwide• LINCOLN

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