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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 - 2011

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TimeTargetPercent
Oct 20108036
Nov 20108048
Dec 20108042
Jan 20118043
Feb 20118057
Mar 20118043
Apr 20118057
May 20118042
Jun 20118045
Jul 20118057
Aug 20118073
Sep 20118072

FY 2011 Overall: 52%

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

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A29
Nov 2010N/A51
Dec 2010N/A39
Jan 2011N/A32
Feb 2011N/A61
Mar 2011N/A66
Apr 2011N/A65
May 2011N/A59
Jun 2011N/A57
Jul 2011N/A58
Aug 2011N/A94
Sep 2011N/A54

FY 2011 Total: 665

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

Fiscal Year - 2011
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TimeTargetNumber
Oct 2010N/A81
Nov 2010N/A106
Dec 2010N/A92
Jan 2011N/A75
Feb 2011N/A107
Mar 2011N/A152
Apr 2011N/A115
May 2011N/A114
Jun 2011N/A128
Jul 2011N/A102
Aug 2011N/A128
Sep 2011N/A75

FY 2011 Total: 1,275

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.