Complete FDA and NHTSA recall records dated in February 2019.
These records include useful source details for the selected month.
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Volkswagen Group of America, Inc. (Audi) is recalling certain 2019 Q7, Q8, S5 Cabriolet, and S5 Sportback vehicles. The front shock absorber forks may develop cracks allowing the shock…
Volkswagen Group of America (Volkswagen) is recalling certain 2019 Jetta vehicles. An incorrect driver frontal airbag may have been installed during a service/repair visit.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
potential for urine leakage around the vent on the vented sample port
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
On the Revolution CT systems equipped with the SmartStep Option, the Z location displayed on image annotation and on the gantry display may not be the actual location of the table and…
It was identified that the volume of air inside the mattress may expand in regions of high altitude which may result in an unintended gap between the plateau of the inflated patient surface…
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
Inability or difficulty in unbuckling/releasing the proning arm buckle might delay patient access in an emergency situation such as cardiac arrest. This, in turn, could contribute to a…
Some SureStep" Foley Tray Systems with product catalog number A319418AM and lot number NGCT1929 contain vented sample ports that may have an increased likelihood of leaking urine from the…
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried out for quality assurance demonstrated that creatinine measurements as determined on…
The Medtronic CareLink Encore 29901 programmer system is comprised of prescription devices indicated for use in the interrogation and programming of implantable medical devices. Prior to…
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the device reaching its Recommended…
Tip of the curing light was too hot causing a heat sensation in the patients.
Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results due to a reagent carryover when testing on board with specific assays on the ARCHITECT i1000SR…
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
A customer site was identified to have three FACSLyric IVD systems with FACSuite clinical v1.1.1 installed on a computer workstation with windows 10 operating system (OS). Windows 10 OS is…
Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
