{"data":{"id":"us/21-cfr-810.13","jurisdiction":"us","citation":"21 CFR 810.13","heading":"Mandatory recall order.","body":"(a) If the person named in a cease distribution and notification order does not request a regulatory hearing or submit a request for agency review of the order, or, if the Commissioner of Food and Drugs or the presiding officer denies a request for a hearing, or, if after conducting a regulatory hearing under § 810.11 or completing agency review of a cease distribution and notification order under § 810.12, FDA determines that the order should be amended to require a recall of the device with respect to which the order was issued, FDA shall amend the order to require such a recall. FDA shall amend the order to require such a recall within 15 working days of issuance of a cease distribution and notification order if a regulatory hearing or agency review of the order is not requested, or within 15 working days of denying a request for a hearing, or within 15 working days of completing a regulatory hearing under § 810.11, or within 15 working days of receipt of a written request for review of a cease distribution and notification order under § 810.12.\n(b) In a mandatory recall order, FDA may:\n(1) Specify that the recall is to extend to the wholesale, retail, or user level;\n(2) Specify a timetable in accordance with which the recall is to begin and be completed;\n(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\n(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.\n(c) FDA will not include in a mandatory recall order a requirement for:\n(1) Recall of a device from individuals; or\n(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.\n(d) FDA will include in a mandatory recall order provisions for notification to individuals subject to the risks associated with use of the device. If a significant number of such individuals cannot be identified, FDA may notify such individuals under section 705(b) of the act.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 810—MEDICAL DEVICE RECALL AUTHORITY","Subpart B—Mandatory Medical Device Recall Procedures"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"d1cea3e2ce80736712d39f658df9468c8e474c844fc30f873ca2e061a0939b31","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-810.12","next":"us/21-cfr-810.14"},"notice":"GroundRules: Original legal text. Not legal advice."}