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 July 2019
| Date | Company | Description of Problem |
| July 23 | Datascope/Getinge | Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i Intra-Aortic Balloon Pumps (IABP) Recalled Due to Potential Battery Failure |
| July 18 | Becton Dickinson (BD) | Alaris Infusion Sets for the Alaris Pump Model 8100 Recalled Due to Potential for Tube Collapse. This May Cause Unintended Delivery or Faster than Expected Delivery of Medication. |
| July 18 | Becton Dickinson (BD) (CareFusion 303 Inc.) | Alaris Pump Module Model 8100 Bezel Assembly Could Result in Free Flow, Over-Infusion, Under-Infusion or Interruption of Infusion |
| July 17 | Teleflex | NEONATAL ConchaSmart Breathing Circuit Recalled Due to Circuit Cracks |
| July 12 | GE Healthcare LLC | Giraffe Infant Warmers and Panda i-Res Infant Warmers Recalled Due to Bedside Panels and Latch Areas Cracking or Breaking |
| July 12 | Hamilton Medical AG | Hamilton-G5 Ventilators Recalled Due to Potential for Sporadic Error Message Resulting in the Ventilator to Cease Ventilation and Enter Ambient State |
| July 1 | Becton Dickinson & Company (BD) | SmartSite Syringe Administration Set Recalled Due to Risk of Leaks |
| July 1 | Edwards Lifesciences | IntraClude Intra-Aortic Occlusion Device Recalled Due to Risk of Balloon Rupture |
