(b) In a mandatory recall order, FDA may:

1. (1) Specify that the recall is to extend to the wholesale, retail, or user level;
2. (2) Specify a timetable in accordance with which the recall is to begin and be completed;
3. (3) Require the person named in the order to submit to the agency a proposed recall strategy, as described in § 810.14, and periodic reports describing the progress of the mandatory recall, as described in § 810.16; and
4. (4) Provide the person named in the order with a model recall notification letter that includes the key elements of information that FDA has determined are necessary to inform health professionals and device user facilities.

(c) FDA will not include in a mandatory recall order a requirement for:

1. (1) Recall of a device from individuals; or
2. (2) Recall of a device from device user facilities, if FDA determines that the risk of recalling the device from the facilities presents a greater health risk than the health risk of not recalling the device from use, unless the device can be replaced immediately with an equivalent device.