Recall

A firm's removal or correction of a marketed product that the FDA considers in violation of the laws it administers and would take legal action against, such as seizure. Market withdrawals and stock recoveries are not recalls. The FDA assigns each recall to Class I, II, or III by health hazard.

Where it is written

21 CFR 7.3(g)

Also called

product recall

Classifications

• Recall Classification (US)The Class I, II, or III designation the FDA assigns to a product recall to show the relative health hazard of the recalled product. The FDA makes the assignment, not the recalling firm. Class I is the most serious and Class III the least.
• Recall Classification (EU)The EU MDR sets no recall classes. It defines a recall as returning a device already made available to the end user, and a withdrawal as stopping a device in the supply chain from being made available.
• Recall Classification (CA)Health Canada's Type I, II, or III designation shows the relative health hazard of a recalled product. The company running the recall assigns the type from a health risk assessment. Health Canada checks that the assigned type is appropriate.

Related terms