According to the FDA, this is a class III recall
which means that use of, or exposure to, the product is not likely to cause adverse health consequences.
In the malfunction report, the company characterized this issue as a Class III recall
, which the FDA defines as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
The presence of a non-allergen that is generally recognized as safe will result in a Class III recall. Id.
(72) Class III recalls involve products that will not cause adverse health consequences.
This regulation categorizes product recalls into three classifications: A Class I recall means the use of the medical device could result in serious damage to health; a Class II recall implies that use of the medical device could induce temporary or recoverable health damage; and a Class III recall
indicates that use of the device generally does not inflict danger to health, and other factors most likely led to the recall.
The FDA said the Class III recall
was initiated by Abbott by letter dated December 22, 1999.
From November 2002 to December 2016, there were 14 class I, 266 class II, and 33 class III recalls involving cosmetic and personal care products, said Timothy M.
Recalls are classified by the FDA according to risk to patient safety: Class I means there is "reasonable probability of causing serious adverse health outcomes or death," class II defines the risk as "temporary or reversible," and class III recalls are "unlikely to cause an adverse health consequence," they explained.
FDA's regulations tend to suggest Class III recalls
may not be needed, as they state FDA will not request a recall unless the product in question "presents a risk of illness or injury or gross consumer deception." FDA's definition of the term "recall" also suggests Class III situations do not belong within its scope, as it pertains to products "against which the agency would initiate legal action."