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Medical device and health technology recalls from FDA. Includes diagnostic equipment, implants, monitors, and therapeutic devices.
Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.
It was determined that the Endotracheal Tube Holder included in certain kits is not compatible with a cricothyrotomy procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.
A decrease in the reactivity of HSV Type 1/2 lgM in the Serology ToRCH lgM Positive Control when tested on the DiaSorin Liaison XL.
Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.
The sterility of microcatheter and infusion system devices cannot be guaranteed.
Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.
AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.
Certain factory settings for the device were incorrectly described in the IFU-related to the warning limits for PVen and PAux, and the default settings for the venous bubble sensor (VBS) and the automatic lock in the Minimized Extracorporeal Circulation (MECC) ThApp
The sterility of microcatheter and infusion system devices cannot be guaranteed.
It was determined that the Endotracheal Tube Holder included in certain kits is not compatible with a cricothyrotomy procedure, leaving practitioners without the necessary means to secure the inserted endotracheal tube.
Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.
Sodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility assurance, which could result in a nonsterile product, use of which could cause infection.
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.
The instruction manuals that were included with the Multi-Mode Stimulators distributed from 2018 to 2023 did not contain all of the appropriate warnings and contraindications.
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.
Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or potential sterility issues due to the cover becoming loose
The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.