(b) Assessment contentThe program established under subsection (a)(1) shall, at a minimum, identify—
(c) DefinitionIn this section, the term “recall” means—
(1)
the removal from the market of a device pursuant to an order of the Secretary under subsection (b) or (e) of section 360h of this title; or
(2)
the correction or removal from the market of a device at the initiative of the manufacturer or importer of the device that is required to be reported to the Secretary under section 360i(g) of this title.
(June 25, 1938, ch. 675, § 518A, as added Pub. L. 112–144, title VI, § 605, July 9, 2012, 126 Stat. 1053; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(K), Dec. 13, 2016, 130 Stat. 1154.)