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Class III: Includes a situation in which use of or recall classification. FDA then places the notice of the
exposure to the product is not likely to cause recall in the FDA Weekly Enforcement Report. Nearly
adverse health consequences. all recalls implemented in the U.S. are begun on a
voluntary basis by the anything we can go to get.
Market withdrawal: When a product has a minor
violation that would not be subject to FDA If a manufacturer has voluntarily initiated a recall, it
legal action a “market withdrawal” occurs. The is the manufacturer’s responsibility to promptly notify
product is removed by the firm from the market each of its direct accounts. If the recall extends beyond
or the firm corrects the violation. direct accounts, then the direct accounts should be
instructed by the recalling manufacturer to contact
Medical device safety alert: Released in sub-accounts that may have received the product.
circumstances in which a medical device may Once all the accounts have been informed about the
present an unreasonable risk of substantial harm. recall, they must promptly follow the recall strategy
These situations also are considered recalls in that was previously put in place for that account.
certain cases.
FDA Requested Recall
Each FDA recall follows specific timelines and In urgent situations, FDA may request a recall. The
procedures depending upon the circumstances. For request is directed to the manufacturer that has
example, each recall is initiated with a written order the primary responsibility for making or marketing
that states the violation, the product, lot and serial the product. Class 1 category recalls are most often
numbers to be recalled, and the timeline for the requested recalls. It is important to note FDA considers
recall. Each recall is unique and requires its own recall an FDA requested recall to be manufacturer initiated.
strategy developed by the Center Recall Unit. The CRU
will consider how far the recall should extend, whether The associate commissioner for regulatory affairs
the public needs to be warned and if so, in what approves all recall requests from FDA. A letter outlining
geographical area, and the appropriate assessment the need for a recall is sent to manufacturer.
for recall effectiveness. A recall designated voluntary, After a recall has begun, the
requested and mandatory depends on recall is entered in the Recall
who initiates the process. Enterprise System. The RES
Based upon the gravity is a database used by FDA
of the situation, FDA will to submit, update, classify
issue a public warning. and terminate recalls.

FDA Mandated Recalls
RECALL METHODS
FDA’s authority to issue

Voluntary Recall: a mandatory recall is very
Initiation of a Recall limited. Subjects of mandatory recalls
by a Manufacturer can include devices, biological products, human tissue
Consistent with its responsibility to protect the public intended for transplantation, infant formula, tobacco
health from products that are defective or potentially products and food. FDA also has discretion to order
harmful, a manufacturer may voluntarily initiate a recall. a mandatory recall if it finds that a human cell, tissue
If a recall is manufacturer-initiated, FDA reviews the or cellular or tissue-based product is a source of
information provided by the manufacturer, conducts a dangerous infection to humans or does not adequately
health hazard evaluation, classifies the recall and then protect against communicable disease.
advises the manufacturer in writing of the assigned

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