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Percent of recalls (I, II, and III) meeting OC timeframes classified during the month

Dictionary: Once a recall occurs, OC assigns a recall classification (Class I, II, or III) to indicate the relative degree of public health risk due to device malfunction. OC prioritizes classifying the recalls that pose the most serious public health risks, namely Class I and high-risk Class II events. OC is able to target these two types of recalls because ORA Districts notify OC when a potential Class I or high-risk Class II occurs. Once CDRH completes the recall classification, ORA monitors and confirms the successful completion of required corrective actions. Currently, these metrics do not distinguish between high-risk Class II and other Class II recalls.

Information is current as of September 30, 2013

Fiscal Year - 2012

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TimeTargetPercent
Oct 20118073
Nov 20118074
Dec 20118085
Jan 20128084
Feb 20128087
Mar 20128090
Apr 20128090
May 20128095
Jun 20128098
Jul 20128094
Aug 20128095
Sep 20128094

FY 2012 Overall: 88%

Total number of recalls (I, II, and III) meeting Office of Compliance classification timeframes during the month

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A53
Nov 2011N/A70
Dec 2011N/A100
Jan 2012N/A96
Feb 2012N/A96
Mar 2012N/A98
Apr 2012N/A66
May 2012N/A82
Jun 2012N/A64
Jul 2012N/A103
Aug 2012N/A123
Sep 2012N/A101

FY 2012 Total: 1,052

Total number of recalls classified (I, II, and III) during the month

Fiscal Year - 2012
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TimeTargetNumber
Oct 2011N/A73
Nov 2011N/A95
Dec 2011N/A117
Jan 2012N/A116
Feb 2012N/A110
Mar 2012N/A109
Apr 2012N/A73
May 2012N/A86
Jun 2012N/A65
Jul 2012N/A110
Aug 2012N/A129
Sep 2012N/A107

FY 2012 Total: 1,190

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.