Class III Recall

A situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
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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 presence of a non-allergen that is generally recognized as safe will result in a Class III recall.
The FSIS issues press releases for all Class I and Class II recalls, and RNRs for Class III recalls.
Public notice of Class III recalls is usually limited to an RNR on the FSIS website.
Because a product label includes a list of ingredients, nutritional information, safety warnings and other critical consumer information, a misprinted label signifies a communication error that most often results in a Class III recall under the direction of the FDA.
The FDA said the Class III recall was initiated by Abbott by letter dated December 22, 1999.