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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 - 2013

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TimeTargetPercent
Oct 20128091
Nov 20128087
Dec 20128095
Jan 20138081
Feb 20138092
Mar 20138092
Apr 20138087
May 20138097
Jun 20138092
Jul 20138095
Aug 20138098
Sep 20138096

FY 2013 Overall: 92%

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

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A77
Nov 2012N/A82
Dec 2012N/A82
Jan 2013N/A56
Feb 2013N/A78
Mar 2013N/A87
Apr 2013N/A104
May 2013N/A89
Jun 2013N/A85
Jul 2013N/A98
Aug 2013N/A60
Sep 2013N/A78

FY 2013 Total: 976

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

Fiscal Year - 2013
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TimeTargetNumber
Oct 2012N/A85
Nov 2012N/A94
Dec 2012N/A86
Jan 2013N/A69
Feb 2013N/A85
Mar 2013N/A95
Apr 2013N/A119
May 2013N/A92
Jun 2013N/A92
Jul 2013N/A103
Aug 2013N/A61
Sep 2013N/A61

FY 2013 Total: 1,062

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.