Recalls of medical devices occur when a company sees a need to either take corrective action or remove a potentially hazardous device from the market, according to the U.S. Food and Drug Administration.
Recalls, which are usually initiated by companies but can also be ordered by the FDA, take place when a device has defects or when it poses dangers to human health, the FDA's website says.
The FDA reviews how companies plan to deal with problems with their devices and can assign a classification of risk to a problem raised by the manufacturer. The FDA can assign one of three classifications: Class 1, referring to a reasonable chance of serious health threats or death; Class II, when a temporary health condition can result, or when there is a small risk of serious injury or death; or Class III, when no health problem or injury is likely.
The agency posts notifications about recalls on its Medical Device Recall Database and may also post company press releases or announcements to warn consumers about such problems.
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Medical Devices Recalled in August 2019
| Date | Company | Description of Problem |
| Aug. 22 | Edwards Lifesciences LLC | SAPIEN 3 Ultra Delivery System Recalled Due to Burst Balloons During Surgery, Which May Result in Vascular Injury, Bleeding or Surgical Intervention |
| Aug. 21 | Medline Industries Inc. | Centurion Medical Products' Primary Warmer Pack and Primary Set Pack Containing Becton Dickinson Alaris Pump Model 8100 Infusion Sets Recalled Due to Potential for Tube Collapse that May Cause Unintended Delivery or Faster-than-Expected Delivery of Medication |
| Aug. 21 | Medline Industries Inc. | Centurion Medical Products' Primary Warmer Pack Containing Vyaire Medical enFlow Fluid Warming Disposable Cartridge Recalled Due to Potential Risk of Exposure to Elevated Levels of Aluminum |
| Aug. 12 | Fresenius Kabi | Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library Recalled Due to a "Low Priority" "Keep Vein Open (KVO), End of Infusion" Alarm and Multiple Software Errors |
| Aug. 5 | Abbott (formerly St. Jude Medical Inc.) | Ellipse Implantable Cardioverter Defibrillators Recalled Due to Exposed Aluminum Wires That May Prevent Defibrillation Therapy |
| Aug. 2 | QIAGEN | Filter Tips for use with the QIAsymphony SP/AS Instruments Recalled Due to Potential to Leak, Which May Result in Delayed or Inaccurate Results |
| Aug. 2 | Centurion Medical Products | Airway Kit Containing Sheridan Endotracheal Tubes Recalled Due to Potential for the Tube Connector to Dislodge, Which May Result in Disconnection of the Patient from the Breathing Circuit |
