1. Recall Basics
Recalls are voluntary removals and/or corrections of marketed products and are utilized as an alternative solution as opposed to FDA-initiated actions, including seizures and import detentions.
2. Reasonable Probability
"Reasonable probability" when utilized as basis for a recall means that it is more likely than not that an event will occur.
3. Removal and Correction: Are they same?
The difference between a removal and a correction is that a correction is handled on-site, without the physical removal of a device from its point of use.
4. Recall Classifications
There are three classifications of recalls, with class I being the most serious. Class I recall is a situation in which there is a reasonable probability that the use of a violative product will cause serious adverse health consequences or death.
5. Recall Communication
The recalling firm which initiates the correction or removal is also responsible for submitting a written report within 10 working days.
Reports submitted by manufacturers or importers do not necessarily reflect a conclusion by the manufacturer, importer, or FDA that the report constitutes an admission that the device caused or contributed to death or serious injury.
7. Enforcement Powers of FDA
The FDA does not sit idly by if recalls are not initiated voluntarily by firms. They issue public notifications, may mandate a recall, seize the products and file court injunctions.
8. FDA Recalls
FDA-ordered recalls may either be extended to the wholesale, retail, or user level.