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Showing 9681–9700 of 35916 results

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Monoject 12 mL Syringe (Cardinal Health) – Pump Compatibility (2023)

Demonstrated recognition and compatibility issues with syringe infusion pumps.

FDASep 20, 2023Nationwide• Cardinal Health 200, LLC

Monoject 20 mL Syringe (Cardinal Health) – Pump Compatibility (2023)

Demonstrated recognition and compatibility issues with syringe infusion pumps.

FDASep 20, 2023Nationwide• Cardinal Health 200, LLC

Monoject 1 mL Tuberculin Syringe (Cardinal Health) – Pump Compatibility (2023)

Demonstrated recognition and compatibility issues with syringe infusion pumps.

Moderate

FDASep 20, 2023Nationwide• Cardinal Health 200, LLC

Monoject 60 mL Syringe (Cardinal Health) – Pump Compatibility (2023)

Demonstrated recognition and compatibility issues with syringe infusion pumps.

FDASep 20, 2023Nationwide• Cardinal Health 200, LLC

BMW 760i (BMW) – Windshield Wipers (2023)

BMW of North America, LLC (BMW) is recalling certain 2023 740i, 760i xDrive and i7 xDrive60 vehicles. The windshield wipers may fail during certain weather conditions.

NHTSASep 20, 2023Nationwide• BMW

Tiffin Allegro Bus (Tiffin) – Cooktop Safety (2023)

Tiffin Motorhomes, Inc. (Tiffin) is recalling certain 2016-2024 Allegro Bus, and 2017-2024 Zephyr motorhomes. The 240-Volt induction cooktop may not be grounded, which can create an electrical shock hazard if the wires short-circuit.

NHTSASep 20, 2023Nationwide• TIFFIN

Wabash National Van (Wabash National) – Lift Gate Bolts (2023)

Wabash National Corporation (Wabash) is recalling certain 2009-2024 dry van trailers equipped with a rail-style lift gate. Please see the recall report for a complete list of models. The location of the rear impact guard is too far forward from the rear of the trailer, reducing impact protection. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 224, "Rear Impact Protection."

NHTSASep 20, 2023Nationwide• WABASH NATIONAL

NeuroSync EYE-SYNC (NeuroSync) – Syncing Problems (2023)

Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuation of support for the Pico 2 platform, which was no longer in production or serviceable as of August 31, 2023.

FDASep 19, 2023Nationwide• NeuroSync, Inc.

Vasoview 6 Pro (Maquet) – Packaging Error (2023)

Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different device.

FDASep 19, 2023AL, AR, CA +10 more• Maquet Cardiovascular, LLC

LeadCare II Test Kit (Magellan) – Plastic Cap Issue (2023)

During an internal audit a small percentage (<10%) of plastic caps used to close the treatment reagent tubes were found to not meet the minimum dimensional lip requirement and may have inadequate cap-to-tube seals. Manufacturing with these caps may result in cap-to-tube seals that allow leaking of HCl or may result in cap-to-tube seals that allow evaporation of treatment reagent. The consequence of this would be a change in the volume of treatment reagent and a change in the ratios of either added patient sample or control material to treatment reagent. The result of this might be a falsely elevated result (e.g., a patient false positive [PATFP] result or a Controls Out of Range-High [COOR-Hi] result).

FDASep 19, 2023Nationwide• Magellan Diagnostics, Inc.

Nova Stat Profile (Nova Biomedical) – Creatinine Results (2023)

Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be identified by traditional Quality Control practices.

FDASep 18, 2023Nationwide• Nova Biomedical Corporation

Head and Neck Procedure Kit (DeRoyal) – Syringe Recall (2023)

DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due to damage to the luer tip of the syringe.

FDASep 18, 2023PA• DeRoyal Industries Inc

Ocean Water Seal Chest Drains (Atrium) – Setup Instructions (2023)

Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains

FDASep 18, 2023Nationwide• Atrium Medical Corporation

Express Dry Seal Chest Drains (Atrium) – Setup Instructions (2023)

Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains

FDASep 18, 2023Nationwide• Atrium Medical Corporation

Nova Prime Plus Analyzer (Nova Biomedical) – Creatinine Results (2023)

Potential risk of reporting erroneous creatinine patient results associated with the initial start-up of a new BUN/Creatinine Sensor Cartridge. The potential risk is within the first 2-4 hours after cartridge installation that may not be identified by traditional Quality Control practices.

FDASep 18, 2023Nationwide• Nova Biomedical Corporation

Jeep Gladiator (Jeep) – Camera Interference (2023)

Chrysler (FCA US), LLC is recalling certain 2022-2023 Jeep Wrangler and Gladiator vehicles equipped with a manual transmission. The rearview camera may fail to display the rearview image and the reverse lights may not illuminate when the vehicle is placed in reverse. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard numbers 111, "Rear Visibility" and 108, "Lamps, Reflective Devices, and Associated Equipment."

NHTSASep 18, 2023Nationwide• JEEP

Mopar Gear Position Sensor (Mopar) – Transmission Issue (2023)

Chrysler (FCA US. LLC) is recalling certain Mopar Gear Position Sensors with part number 68331278AB, and Transmission Assemblies with part numbers 05106257AG and 05106257AF. When the sensors or transmission assemblies are installed into a vehicle, the rearview camera may fail to display the rearview image and the reverse lights may not illuminate when the vehicle is placed in reverse. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard numbers 111, "Rear Visibility", and 108, "Lamps, Reflective Devices, and Associated Equipment."

NHTSASep 18, 2023Nationwide• MOPAR

Hyundam Industrial Fuel Pump (Hyundam) – Impeller Defect (2023)

Hyundam Industrial (Hyundam) is recalling certain fuel pumps. Please see the recall report for a complete list of part numbers. The impeller inside the fuel pump may deform, which can cause fuel pump failure.

NHTSASep 18, 2023Nationwide• HYUNDAM INDUSTRIAL

Dodge Durango (Dodge) – Shifter Problem (2023)

Chrysler (FCA US, LLC) is recalling certain 2023 Dodge Durango Pursuit vehicles equipped with an instrument panel mounted shifter. The shifter may experience an interference with the shifter boot and come out of gear while driving, which can result in a sudden loss of drive power.

NHTSASep 18, 2023Nationwide• DODGE

Oasis Dry Suction Chest Drains (Atrium) – Setup Instructions (2023)

Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains

FDASep 18, 2023Nationwide• Atrium Medical Corporation

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