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All product recalls affecting New York.
Includes nationwide recalls (tagged “Nationwide”) and recalls with New York in the distribution area.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Custom Truck and Body Works (Custom Truck) is recalling certain 2020 Ford F-550 vehicles equipped with Weldon 8X16 Input-Output nodes. In the event of a short circuit or wiring failure, the firmware in the node may fail to shut off the output pin, resulting in overloaded electrical circuits.
Undeclared colors (FD&C Yellow #5, FD&C Blue #1, and FD&C Red #40)
Due to a risk of false positive results that could lead to unnecessary medical treatment.
Mercedes-Benz USA, LLC (MBUSA) is recalling certain 2024 GLE 350 4MATIC, 2025 GLE 450e 4MATIC, GLE 450 4MATIC Coupe, GLE 450 4MATIC, GLS 450 4MATIC, Maybach GLS 600 4MATIC, AMG GLE 53 4MATIC, AMG GLE 53 4MATIC Coupe, AMG GLE 63 S 4MATIC Coupe, and AMG GLS 63 4MATIC vehicles. The multi-purpose camera and the rearview mirror may be insufficiently attached to the windshield and may detach.
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
Orange EV is recalling certain 2023-2025 HUSK-e, e-TRIEVER, and 2022-2024 T-Series trucks. The bolts securing the upper steering shaft clamp may have been improperly tightened.
Kit USB flash drive contains outdated software, which could result in reverting patient monitor to outdated software and reintroducing the video laryngoscope issue (related to an August 2023 recall), which could lead to delay in diagnosis, delayed treatment, hypoxia due to unexpected loss of video laryngoscopy and all other monitor measurements during system restart.
Marketed Without an Approved NDA/ANDA
Forest River Bus, LLC (Forest River Bus) is recalling certain 2025 Collins Bus transit buses. The lock on the emergency exit door may fail to unlock. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 217, "Bus Emergency Exits and Window Retention and Release."
Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.
Forest River Bus, LLC (Forest River Bus) is recalling certain 2023-2027 Collins Bus school buses. The lock on the emergency exit door may fail to unlock. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 217, "Bus Emergency Exits and Window Retention and Release."