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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 - 2010

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TimeTargetPercent
Oct 20098029
Nov 20098030
Dec 20098037
Jan 20108023
Feb 20108028
Mar 20108023
Apr 20108056
May 20108053
Jun 20108057
Jul 20108060
Aug 20108053
Sep 20108030

FY 2010 Overall: 40%

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

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A6
Nov 2009N/A28
Dec 2009N/A22
Jan 2010N/A10
Feb 2010N/A11
Mar 2010N/A30
Apr 2010N/A48
May 2010N/A42
Jun 2010N/A27
Jul 2010N/A39
Aug 2010N/A51
Sep 2010N/A34

FY 2010 Total: 348

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

Fiscal Year - 2010
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TimeTargetNumber
Oct 2009N/A21
Nov 2009N/A92
Dec 2009N/A51
Jan 2010N/A49
Feb 2010N/A30
Mar 2010N/A133
Apr 2010N/A85
May 2010N/A79
Jun 2010N/A65
Jul 2010N/A48
Aug 2010N/A96
Sep 2010N/A113

FY 2010 Total: 874

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.