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  1. Recalls (Biologics)

CBER FY 2019 Recall Postings

Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

CBER FY 2019 Recall Postings
  Allergenic Blood Blood Deriv. Device IVD Source Plasma Therapeutic Tissue Vaccine Total Events
by Class
Class I       1       1   2
Class II   289 3 5   30   13   340
Class III 1 121 2 5 1 227     1 358
Mixed Class (Cl.
I/II)
              2   2
Mixed Class (Cl.
I/III)
                  0
Mixed Class (Cl.
II/III)
  33               33
Total Events
by Product
1 443 5 11 1 257   16 1 735
Direct Recall Classification (DRC) Related Data - 2019
Number of AI Requests during FY 19 754
Number of Alerts to Possible Recall sent during FY 19 0
Number of DRC Recalls Classified during FY19 720

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