Table 3

Assessment of the relative degree of health hazard by Food and Drug Administration (FDA) classification of recalls for medical-device alerts

ReviewerFDA recall Class IFDA recall Class IIFDA recall Class IIIUncertain
Reviewer 1177 (39.6)205 (45.9)32 (7.2)33 (7.4)
Reviewer 2189 (42.3)169 (37.8)66 (14.8)23 (5.1)
Agreed total*197 (44.1)168 (37.6)54 (12.1)28 (6.3)
  • * κ for overall agreement 0.6.