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Showing 8141–8160 of 35916 results

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Fluticasone Nasal Spray (Golden State Medical) – bacterial contamination risk (2024)

CGMP Deviations:Suspected potential presence of Burkholderia cepacia complex

Class IIModerate

FDAFeb 14, 2024Nationwide• Golden State Medical Supply Inc.

GeoMed Tracecarts (DeRoyal) – Component Recall Risk (2024)

DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.

FDAFeb 13, 2024FL• DeRoyal Industries Inc

Waymo 5th Gen ADS (Waymo) – Software Positioning Issue (2024)

Waymo LLC (Waymo) is recalling certain 5th Generation Automated Driving Systems (ADS) with software versions released prior to December 20, 2023. The ADS systems may inaccurately predict the movement of a towed vehicle.

Moderate

NHTSAFeb 13, 2024Nationwide• WAYMO

CFMOTO 450SS (CFMOTO) – Telematics Box Problem (2024)

CFMOTO POWERSPORTS, INC. (CFMOTO) is recalling certain 2023 450SS motorcycles. The telematics box (T-box) may fall onto the front steering forks, which can cause a loss of steering control.

NHTSAFeb 13, 2024Nationwide• CFMOTO

Hyundai Palisade (Hyundai) – Engine Valve Problem (2024)

Hyundia Motor America (Hyundai) is recalling certain 2024 Palisade vehicles. The engine valve springs may break while driving, which can result in a loss of drive power and possibly create a hole in the engine block.

NHTSAFeb 13, 2024Nationwide• HYUNDAI

Hyundai Genesis (Hyundai) – Electrical Water Damage (2024)

Hyundai Motor America (Hyundai) is recalling certain 2015-2016 Genesis, 2017-2019 Genesis G80, Genesis G90, and 2019 Genesis G70 vehicles. Water may enter the starter solenoid and cause an electrical short, which can result in an engine compartment fire while parked or driving.

NHTSAFeb 13, 2024Nationwide• HYUNDAI

AGV Tourmodular Helmet (AGV) – Chin Strap Safety Issue (2024)

Dainese S.p.A. (Dainese) is recalling certain AGV Tourmodular helmets. The micrometric buckle may fail to automatically engage, allowing the chin strap to remain loose.

NHTSAFeb 13, 2024Nationwide• AGV

Belmont Trailer FlatTrak (Belmont) – Spindle Mount Crack (2024)

Belmont Trailers LLC (Belmont) is recalling certain 2023-2024 FlatTrak trailers. The spindle mount may crack, resulting in the spindle mount and spindle arm separating.

NHTSAFeb 13, 2024Nationwide• BELMONT TRAILER

Forest River FR3 (Forest River) – LPG Tank Mounting Risk (2024)

Forest River, Inc. (Forest River) is recalling certain 2019-2024 Georgetown and FR3 Class A motorhomes. The liquid petroleum gas (LPG) tank mounting brackets may break, which can result in the LPG tank becoming dislodged and damaged.

NHTSAFeb 12, 2024Nationwide• FOREST RIVER

BMW X7 (BMW) – Brake Control Module Problem (2024)

BMW of North America, LLC. (BMW) is recalling certain 2023-2025 BMW, MINI, and Rolls-Royce vehicles. Please see the recall report for a complete list of models and model years. The integrated brake (IB) system may malfunction and result in a loss of power brake assist or cause the Antilock Brake (ABS) and Dynamic Stability Control (DSC) systems to not function properly.

NHTSAFeb 12, 2024Nationwide• BMW

TMini Knee Instrument (Think Surgical) – Array Guide Issue (2024)

There is a galling effect (cold-weld) caused by friction between the array fixation pins and the TMINI array guide holes due to insufficient clearance between the outer diameter of the fixation pins and the inner diameter of the TMINI array guide holes. As a result, the array guide has the possibility of binding to the array fixation pins during drilling.

FDAFeb 12, 2024Nationwide• Think Surgical, Inc.

POLARSHEATH Steerable Sheath (Boston Scientific) – Manufacturing Defect (2024)

Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing of the sheath or introduction of the dilator or ablation catheter).

FDAFeb 12, 2024Nationwide• Boston Scientific Corporation

QuickFlash Artery Catheterization (Arrow) – Component Defect (2024)

Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to resistance of the guidewire handle/chamber during use. The possible immediate health consequences of the component issue are arterial vasospasm and vessel injury arising from multiple arterial punctures with repeated attempts.

FDAFeb 12, 2024Nationwide• ARROW INTERNATIONAL Inc.

Curaplex Intubation Kit (Sarnova) – Tube Holder Incompatibility (2024)

Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.

FDAFeb 12, 2024Nationwide• Sarnova HC, Llc

Clobazam Tablets (Micro Labs) – Residual Solvent Issue (2024)

CGMP Deviations: Out of specification for residual solvents.

Class IIModerate

FDAFeb 12, 2024Nationwide• Micro Labs Limited

Vermeer BC1800XL (Vermeer) – Tongue Weldment Crack (2024)

Vermeer Manufacturing Company (Vermeer) is recalling certain 2016-2024 BC1800XL brush chipper trailers. The tongue weldment may crack and separate from the tow hitch.

NHTSAFeb 9, 2024Nationwide• VERMEER

Brazil Seed 2-Pack (HandNatural) – Yellow Oleander Risk (2024)

Product recalled due to the presence of yellow oleander and its components in the product.

FDAFeb 9, 2024Nationwide• HandNatural

Bugatti Chiron (Bugatti) – Safety Chime Malfunction (2024)

Bugatti is recalling certain 2016-2023 Bugatti Chiron vehicles. The audible chime may not activate when the vehicle starts, and the driver has not buckled their seat belt. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 208, "Occupant Crash Protection."

NHTSAFeb 9, 2024Nationwide• BUGATTI

Shepard Steering Gears (Shepard) – Gear Box Risk (2024)

R.H. Sheppard Co., Inc. (R.H. Sheppard) is recalling certain steering gears. Please see the recall report for a complete list of all affected models and part numbers. The steering gear sector shaft may have been improperly heat-treated, which can cause the gear teeth to crack or fracture.

NHTSAFeb 9, 2024Nationwide• SHEPARD

Forest River Aurora (Forest River) – Tire Slide Contact Issue (2024)

Forest River, Inc. (Forest River) is recalling certain 2024 Coachmen Catalina and Forest River Aurora travel trailers. The tire may contact the slide adjustment bolt and puncture the tire.

NHTSAFeb 9, 2024Nationwide• FOREST RIVER

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