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Showing 10541–10560 of 35905 results

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Profile Zero Auto-Drive Screw (Osteomed) – Screwhead Size Risk (2023)

Screws for osteotomies have contain an undersize screwhead which has the potential to pass through the plate hole.

FDAMay 31, 2023Nationwide• Osteomed, LLC

COULTER DxH Diluent (Beckman Coulter) – Specification Deviation (2023)

Specific diluent lot numbers showed that conductivity, osmolality, and pH were out of manufacturing specifications.

FDAMay 31, 2023Nationwide• Beckman Coulter, Inc.

Bugatti Chiron Super Sport (BUGATTI) – Incorrect Wheel Installation (2023)

Bugatti (Bugatti) is recalling one 2023 Chiron Super Sport vehicle. The incorrect wheels were installed on the vehicle.

Moderate

NHTSAMay 31, 2023Nationwide• BUGATTI

Prima TT Genoid Monoblock Baseplate (Limacorporate) – Hole Specification Issue (2023)

Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.

FDAMay 30, 2023Nationwide• Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy

VERITAS Infusion Packs (Johnson & Johnson) – Housing Weld Defect (2023)

Weld protrusion/physical gap between the housing and pack cover, may exceed design specification, due to a manufacturing issue, which could lead to priming cycle failure and/or suboptimal vacuum delivered to the phacoemulsification and irrigation/aspiration handpieces during surgery, which could result in surgical delay and/or longer surgical time, which could result in transient corneal edema.

FDAMay 30, 2023Nationwide• Johnson & Johnson Surgical Vision, Inc.

Acetabular Fixation Cup (Synovo) – FDA Approval Missing (2023)

Medical device components were marketed without FDA clearance and without FDA approval

FDAMay 30, 2023Nationwide• Synovo Production

GE Vivid S60N Ultrasound (GE Vingmed) – System Boot Delay (2023)

GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.

FDAMay 30, 2023Nationwide• GE Vingmed Ultrasound As Strandpromenaden 45 Horten Norway

GE Vivid S70 Ultrasound (GE Vingmed) – System Boot Delay (2023)

GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.

FDAMay 30, 2023Nationwide• GE Vingmed Ultrasound As Strandpromenaden 45 Horten Norway

Prima TT Genoid Baseplate (Limacorporate) – Hole Specification Issue (2023)

Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.

FDAMay 30, 2023Nationwide• Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy

Acetabular Bearing (Synovo) – FDA Clearance Concern (2023)

Medical device components were marketed without FDA clearance

FDAMay 30, 2023Nationwide• Synovo Production

Femoral Resurfacing Cup (Synovo) – FDA Clearance Concern (2023)

Medical device components were marketed without FDA clearance

FDAMay 30, 2023Nationwide• Synovo Production

Wabash National Dry Van (WABASH NATIONAL) – King Pin Welding Defect (2023)

Wabash National Corporation (Wabash) is recalling certain 2024 DVDBHPC and DVCVHPC dry van trailers. The king pin was not welded properly, which can result in the king pin detaching within the upper coupler.

NHTSAMay 30, 2023Nationwide• WABASH NATIONAL

Alfa Romeo Stelvio (ALFA ROMEO) – Brake System Concern (2023)

Chrysler (FCA US, LLC) is recalling certain 2017-2020 Alfa Romeo Giulia and 2018-2020 Alfa Romeo Stelvio vehicles equipped with carbon ceramic matrix brakes. During certain driving maneuvers, the brake system may exert an excessive clamp force that may fracture the rotor, decreasing the brake performance.

NHTSAMay 30, 2023Nationwide• ALFA ROMEO

Tesla Model Y (TESLA) – Steering Wheel Fastener Issue (2023)

Tesla, Inc. (Tesla) is recalling certain 2022-2023 Model Y vehicles. The steering wheel fastener may be loose.

NHTSAMay 30, 2023Nationwide• TESLA

Toyota Corolla Cross (TOYOTA) – Instrument Panel Defect (2023)

Toyota Motor Engineering & Manufacturing (Toyota) is recalling certain 2022-2023 Corolla Cross vehicles. The instrument panel may have been produced without the required perforation, which could result in the front-passenger air bag not deploying properly. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safey Standard number 208, "Occupant Crash Protection."

NHTSAMay 30, 2023Nationwide• TOYOTA

Custom Medical Procedure Packs (DeRoyal) – Package Seal Compromise (2023)

The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

FDAMay 30, 2023Nationwide• DeRoyal Industries Inc

Alinity ci-series Control Module (Abbott) – System Performance Issues (2023)

There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the assay information downloaded from SCC; 5) The assay editor does not correctly check sample dilution total volume limits; 6) User-Applied Labels not adhering to Reagent Bottles; 7) ICT Module did not expire after warranty was exceeded. These performance issues could lead to erroneous results for multiple analytes.

FDAMay 30, 2023AL, AK, AZ +43 more• Abbott Laboratories

GE Vivid S60 Ultrasound (GE Vingmed) – System Boot Delay (2023)

GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.

FDAMay 30, 2023Nationwide• GE Vingmed Ultrasound As Strandpromenaden 45 Horten Norway

GE Vivid S70N Ultrasound (GE Vingmed) – System Boot Delay (2023)

GE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.

FDAMay 30, 2023Nationwide• GE Vingmed Ultrasound As Strandpromenaden 45 Horten Norway

Lincoln MKC (LINCOLN) – Battery Sensor Fire Risk (2023)

Ford Motor Company (Ford) is recalling certain 2015-2019 Lincoln MKC vehicles. The battery monitor sensor may short-circuit and overheat, causing a fire in the engine compartment while parked or driving.

NHTSAMay 26, 2023Nationwide• LINCOLN

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