Recall

The word triggers different obligations in each market, so a field action has to be classified separately for each. In the EU, a recall is usually handled as a field safety corrective action with a field safety notice, while in the US the action may also need a correction and removal report under 21 CFR 806.

‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user;

EU MDR, Article 2(62)

‘recall’ means any measure aimed at achieving the return of a device that has already been made available to the end user;

IVDR, Article 2(65)

Recall means a firm's removal or correction of a marketed product that the Food and Drug Administration considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.

21 CFR, 7.3

The MDR and IVDR define a recall by its aim: getting back devices that have already been made available to the end user. 21 CFR 7.3 defines it as a firm's removal or correction of a marketed product that FDA considers violative and would take legal action against, and it expressly excludes market withdrawals and stock recoveries.