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MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide
A potential for a light system to fall in the operating room.
Firm received reports of customers experiencing noise from the NIM System, lead-off or high impedance issues, or loss of/intermittent nerve monitoring,
Mack Trucks, Inc. (Mack) is recalling certain 2024 MD trucks. The steering wheel attachment bolt may loosen and separate from the steering shaft, causing the steering wheel to detach.
Cruise LLC (Cruise) is recalling a subsystem within the Automated Driving Systems (ADS). The Collision Detection Subsystem may improperly cause the vehicle to attempt to move to the side of the road after a crash.
Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis
PACCAR Incorporated (PACCAR) is recalling certain 2024 Peterbilt 520 vehicles. The rear lifting bracket that attaches to the engine cylinder head may be insufficiently secured, which can allow it to detach.
Potentially defective utility trays in the reagent kits.
Custom Fire Apparatus, Inc (Custom Fire) is recalling certain 2021-2024 Spartan Gladiator, MetroStar, and FC-94 emergency vehicles. A defect in the inversion valve may delay the park brake setting after engagement, which could allow the vehicle to move unintentionally.
Alexis Fire Equipment Company (Alexis Fire) is recalling certain 2021-2024 Fire Apparatus vehicles built on Spartan Chassis. A defect in the inversion valve may delay park brake engagement, which could allow the vehicle to move unintentionally. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 121, "Air Brake Systems."
GE HealthCare has become aware of the potential that incorrect torque has been applied to certain bolts of the Definium Tempo and Definium Tempo Pro products which may result in a potential fall of elements of the Overhead Tube Suspension (OTS) assembly.
Hole(s) to the outer pouch of the Introducer Kits (both trayed and non-trayed) may compromise the sterile barrier of the Introducer Kits. Non-sterile product exposes patients to the possibility of the introduction of micro-organisms into the vasculature and/or access site, leading to an infectious process, bacteremia or sepsis.