Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 601–612 of 634 recalls
There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of…
Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more.…
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Due to internal venturi component getting transiently stuck in the forward position within the breathing circuit and may cause a reduction of amplitude and volume of ventilation.
Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
There is an issue with the ventilator battery charger that could lead to an audible and visual alarm. If the alarm is engaged, the ventilator becomes inoperable.
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…