🏥 Medical Devices • 15,809 recalls
A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential for bolt back-out or migration by emphasizing the need for supplemental fixation.
Abbott Laboratories
Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates assigned by Supplier.
GE Healthcare
GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation Volume Guarantee (PCV-VG) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). Exposure to excessiv
GE Healthcare
GE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the Engstr¿m ventilator and the Aespire View, Aisys, and Avance anesthesia machines. As a result of a manufacturing issue, the buttons on the left, right, and bottom keypads may not always detect button presses. This may result in the inability to access certain menu functions wh
The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time, causing increased current drain that can lead to premature battery depletion.
Atrium Medical
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Atrium Medical
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Atrium Medical
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable.
Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective.
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Atrium Medical
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Atrium Medical
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual products) from one (1) lot [(IV1V3) 62 cases, 310 products]of King LTSD Oropharyngeal Airways because the package label indicated that the airway was a size 5 when in fact the airway in the package was a size 4. When King manufacturers a lot, all of the components are the same size, part number etc. I