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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 January-February 2019
| Date | Company | Description of Problem |
| Feb. 27 | Physio-Control | LIFEPAK15 monitor/defibrillator at risk of "lockup" |
| Feb. 22 | ICU Medical | ChemoLock Vial Spike (20-mm) at risk of detached plastic particles |
| Feb. 15 | Medtronic Inc. | Possible circuit error in Dual-Chamber Implantable Pulse Generators |
| Feb. 5 | Edwards Lifesciences | Incorrect assembly caused reversal of lumens in Swan-Ganz Thermodilution Catheter |
| Feb. 4 | Medex Cardio-Pulmonary | Potential exposure to infectious agents due to leaking containers of sterile saline and sterile water for inhalation |
| Feb. 1 | West Pharmaceutical Services Inc. | Potential malfunctions of Vial2Bag Fluid Transfer Systems |
| Feb. 1 | Terrific Care LLC | Inaccurate test results in CoaguChek XS PT Test Strips, which monitor the blood thinner Warfarin |
| Jan. 25 | Draeger Medical | Issue with breathing circuits and anesthesia sets |
| Jan. 8 | Medtronic Inc. | Inaccuracies displayed on Synergy Cranial Software and Stealth Station S7 Cranial Software during surgeries |
