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During global post market surveillance activities cases have been reported that the sampling pump 6873493 shows a changing characteristic with increasing operating time, which can lead to the deactivation of the gas measurement during operation. The…

Since Nov. 2020, Arjo has become aware of 2 customer complaints involving overheating of metal part of the device located underneath its frame. The part involved is referred to as the e-bay box. No adverse health consequences (including temporary or…

During continuous post market surveillance, Draeger gathered information and market feedback indicating that there is a need to provide additional information in the instructions for use regarding the potential of the user to incorrectly position the…

The complaint bottle contains Naphazolin HCl 0.013% and Glycern 0.26%. 

Karl Ttorz Endoscopy Canada is conducting a field action for specific serial numbers of C-View endoscopes with the potential to lose image when monopolar electrocautery is activated. Recall start date: May 2, 2022

The STO2 values may be inaccurately low when using either the fore-sight elite tissue oximeter module (Model HEMFSM10) or the fore-sight elite absolute tissue oximeter monitor (Model 01-06-3000) with the fore-sight elite large sensor (…

Carescape R860 ventilators, and Engström Carestation and Engström Pro ventilators with affected field replacement batteries - insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply…

Customer complaint on over-inflation (abnormal inflation issue) occurring during the product installation, Preparation to initiate therapy or product use. In none of those events, any injury or health consequences were reported. the products in the…

Reports of products having torn corrugated breathing tube.   - Should a tear be detected before use, a delay may be experienced while another product is located.   - Should a tear be detected during use, this may result in a leak and…

A software update for carelink SmartSync™ device managers (SmartSync) will address a telemetry error that may occur with Medtronic Cobalt™ and Crome™ Implantable Cardioverter Defibrillators (ICDs), and Cardiac Resynchronization Therapy Defibrillators (…

Issue 1 - Indication of block movements function: When the operator activates the functions "block movements" or "block table movements" by pressing the block movements button on the pilot control module, there will be a dedicated message displayed on…

An increase in complaints related to incomplete seals or the dressing been trapped in packaging was observed. As a potential hazard associated with these complaints involve the dressing being open or the product being sealed within the same primary…

Customer complaint on over-inflation (abnormal inflation issue) occurring during the product installation, preparation to initiate therapy or product use. In none of those events, any injury or health consequences were reported. The products in the…

The ook snow ALL when used with motorized wheel system, and bearing the option number OL2000200WG may continue to move forward even after the trigger was released. Recall start date: Apr 11, 2022

Bd has confirmed through internal investigation that these products may exhibit an uncharacteristic flow profile. Our investigation confirmed there was an error during the manufacturing process. Recall start date: Apr 20, 2022