Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,105–1,116 of 1,121 recalls
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.
The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or Excessive Weight Mismatch Alarms while in use.…
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Art…
Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Art…
Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.
Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.
The extension sets subject to this recall have ENFit connections, although they should have non- ENFit connections. ENFit connectors will only fit with other ENFit-compatible devices, and will not fit with non-ENFit conn…
Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylus when connected to the Aerin Console.
Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers.…
Software issues were identified in application version 2.x.
Software issues were identified in application version 2.x.