Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 49–60 of 816 recalls
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in…
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in…
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in…
Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under f…
Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label.
Due to incorrect functional length on device labeling.
Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System.…