Manufacturers and distributors of medical devices may voluntarily issue a recall if they discover that a product has a flaw or defect that compromises quality or safety. The recall actions may service, correct or replace the device, or may provide instructions for the consumer to do so.
When safety is an issue, companies must report the recall to the U.S. Food and Drug Administration and submit a recall strategy.
The action receives one of three classifications based on the FDA’s health hazard evaluation:
- Class III: The FDA classifies the action as a Class III recall if patients with the recalled device are not likely to experience adverse health issues.
- Class II: This recall involves a faulty device that could cause a treatable injury or illness from which patients are not likely to experience any long-term or serious effects.
- Class I: Manufacturers must issue this level of recall when their products are likely to cause serious injury and possibly death.
The recall may include a public warning through news media, professional channels, certified letters marked “urgent,” phone calls, personal visits or a combination of methods. The recall strategy may require confirmed contact with 100% of those who received the device in Class I recalls, but Class II and III recalls may require a lower percentage or fewer effectiveness checks.
The FDA may adjust the recall strategy if necessary and then will ensure that the company carries it out properly. Information about specific medical device recalls, including updates and warnings to the public, to medical providers and to manufacturers, is available on the FDA’s website.