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All product recalls affecting Maine.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Maine in the distribution area.
There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded.
International Motors, LLC (International) is recalling certain 2025-2026 HV, HX, LT, MV, RH, and 2025 EMV vehicles. The linkage that connects the right-side wiper arm to the motor may separate, causing the wipers to fail.
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Potential breach of sterile barrier packaging.
Ford Motor Company (Ford) is recalling certain 2015 F-250, F-350, F-450, Expedition, Lincoln Navigator, and MKC vehicles. The rearview camera printed circuit board terminal header connector may be loose or damaged, which can result in a blank or distorted image.
Potential breach of sterile barrier packaging.
Potential breach of sterile barrier packaging.
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Potential breach of sterile barrier packaging.
Potential breach of sterile barrier packaging.
cGMP deviations and lack of assurance of sterility.
cGMP deviations and lack of assurance of sterility.
Ford Motor Company (Ford) is recalling certain 2023 F-150 Lightning vehicles. The fasteners that secure the junction box bus bars inside the high-voltage battery pack may not have been tightened securely, which can cause electrical arcing at the busbars.
cGMP deviations and lack of assurance of sterility.
cGMP deviations and lack of assurance of sterility.
cGMP deviations and lack of assurance of sterility.
Ford Motor Company (Ford) is recalling certain 2025 F-150 vehicles. The air bag warning label may be missing from the dashboard. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 208, "Occupant Crash Protection."
Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.