When a medical device is recalled, there is often a delay between the manufacturer’s initiation of a correction or removal and the FDA’s recall announcement. In an effort to reduce the confusion that often ensues among healthcare providers and patients, CDRH has changed how it communicates device recalls. As of January 3, the center is posting recall information right when a manufacturer takes the correction or removal actions and notifies CDRH that it can be posted in the Medical Device Recalls database, as opposed to the time of FDA’s recall classification. The information will also be posted in the OpenFDA Device Recalls API.
The process and timelines for reporting corrections and removals is not changing.
The Medical Device recalls database also includes correction or removal actions initiated by a firm prior to recall classification. The status is updated if FDA identifies a violation and classifies the action as a recall; it is updated again when the recall is terminated.