Medical Device Recalls

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class="clearfloat"> - </div>      <span id="user_provided"> <style> .res { color: #000000; width: 900px; float: right; margin: 0px 25px 0px 0px; } .res-left { color: #000000; float: left; width: 610px; margin: 9px 30px 0px 0; } .res-right { color: #000000; float: right; width: 190px; margin: 9px 18px 0 0; padding: 8px 12px 10px 12px; background-color: #f3f3f3; border: 1px solid #b0b0b0; border-radius: 6px; } .res-intro { margin: 0 0 18px 0; padding: 5px 12px 12px 12px; background-color: #e8eff5; border: 1px solid #b0b0b0; border-radius: 6px; } #res-form { table-layout:fixed; width: 610px; font-size: 11px; border: 1px solid #b0b0b0; } #res-form-title{ padding: 6px 6px 6px 6px; width: 100%; background-color: #e8eff5; border-bottom: 1px solid #b0b0b0; margin-top: 0px; } #res-form-title-left { font-size: 13px; font-weight: bold; } #res-form-title-right { font-size: 11px; padding: 0px 0px 0px 450px; } #res-nav { float: center; width: 800px; text-align:center; } #res-results-table { float: center; width: 800px; text-align:center; padding: 0; border-collapse:collapse; table-layout:center; background-color: #e8eff5; border-color: #b0b0b0; border-width: 0 0 1px 1px; border-style: solid; } #res-results-table th { padding: 6px 12px; background-color: #e8eff5; border-color: #b0b0b0; border-width: 1px 1px 0 0; border-style: solid; font-size: 12px; } #res-results-table td { padding: 6px 12px; border-color: #b0b0b0; border-width: 1px 1px 0 0; border-style: solid; text-transform: capitalize; } #res-results-table tr:nth-child(odd) { background-color: #f3f3f3; } .sort { float: right; margin-top: 5px;} .sort a { color: #484138; } .sort a:hover { color: #0f2a8c; } </style> <script language="javascript1.1" type="text/javascript" src="../validate_date.js"></script> <script language="javascript1.1" type="text/javascript" src="../datepicker.js"></script> <script type="text/javascript">  </script>  <div class="res"> <div class="res-left"> <div class="res-intro"><p>This database contains Medical Device Recalls classified since November 2002. Since January 2017, it may also include correction or removal actions initiated by a firm prior to review by the FDA. The status is updated if the FDA identifies a violation and classifies the action as a recall and again when the recall is terminated. FDA recall classification may occur after the firm recalling the medical device product conducts and communicates with its customers about the recall. Therefore, the recall information posting date ("create date") indicates the date FDA classified the recall, it does not necessarily mean that the recall is new. <A href="http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/default.htm" ref="nofollow" style="text-decoration:underline;">CBER recall information is available here</A>.     <a href="http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm329946.htm" style="text-decoration:underline;">More about Medical Device Recalls</a></p></div> <div id="res-form"> <table align="center" width="100%" id="res-form-title"> <tr> <td id="res-form-title-left">Search Database</td> <td id="res-form-title-right"><a href="/scripts/cdrh/cfdocs/search/default.cfm?FAQ=true"><img src="/scripts/cdrh/cfdocs/images/questionmark.gif"></a> <a href="/scripts/cdrh/cfdocs/search/default.cfm?FAQ=true">Help</a> </td> </tr> </table> <form action="./res.cfm" method="post" name="basicsearch" onreset="status='';" autocomplete="off"> <table bgcolor="#f9f9f3" width="100%" border=0 cellpadding="3" cellspacing="3" align="center" style="font-family: arial; color: #000000;"> <tr> <td align="left"><label for="productdescriptiontxt">Product Name</label></td> <td><input type="text" name="productdescriptiontxt" maxlength="30" size="25">     <label for="productcode" style="font-weight:normal;">Product Code</label>     <input type="text" name="productcode" maxlength="3" size="3">     <label for="IVDProducts" style="font-weight:normal;">In Vitro Devices</label>     <input type="Checkbox" name="IVDProducts" > </td> </tr> <tr valign="baseline"> <td style="font-weight:normal;"><label for="centerclassificationtypetext">Recall Class</label></td> <td style="font-weight:normal;"> <select name="centerclassificationtypetext"> <option id="" value="" selected>All</option> <option id="1" value="1">1</option> <option id="2" value="2">2</option> <option id="3" value="3">3</option> <option id="NC" value="NC">not yet classified</option> </select>      <label for="PMA_510K_Num" style="font-weight:normal;">PMA/510(K) Number</label>   <input type="text" name="PMA_510K_Num" maxlength="15" size="12"> </td> </tr> <tr valign="baseline"> <td align="left"><label for="postdatefrom">Recall Date</label></td> <td colspan="2" align="left"> <input type="text" name="postdatefrom" id="postdatefrom" value="" size="10" maxlength="10"> <a href="javascript:show_calendar('basicsearch.postdatefrom');" onmouseover="window.status='date picker';return true;" onmouseout="window.status='';return true;"><img src="../images/show-calendar.gif" width="24" height="22" border="0" alt="use calendar to select date"></a> <label for="postdateto" style="font-weight:normal;">to</label>  <input type="text" name="postdateto" id="postdateto" value="" size="10" maxlength="10"> <a href="javascript:show_calendar('basicsearch.postdateto');" onmouseover="window.status='date picker';return true;" onmouseout="window.status='';return true;"><img src="../images/show-calendar.gif" width="24" height="22" border="0" alt="use calendar to select date"></a>    <label for="recallnumber">Recall Number</label>    <input type="text" name="recallnumber" maxlength="15" size="10"> </td> </tr> <tr> <td style="font-weight:normal;"><label for="productshortreasontxt">Reason for Recall</label></td> <td><input type="text" name="productshortreasontxt" maxlength="30" size="50"></td> </tr> <tr> <td style="font-weight:normal;"><label for="firmlegalnam">Recalling Firm</label></td> <td><input type="text" name="firmlegalnam" maxlength="100" size="50"></td> </tr> <tr> <td style="font-weight:normal;"><label for="rootCauseText">Root Cause</label></td> <td> <select name="rootCauseText" id="rootCauseText"> <option value="" selected> <option value="Component change control">Component change control <option value="Component design/selection">Component design/selection <option value="Counterfeit">Counterfeit <option value="Device Design">Device Design <option value="Employee error">Employee error <option value="Environmental control">Environmental control <option value="Equipment maintenance">Equipment maintenance <option value="Error in labeling">Error in labeling <option value="Finished device change control">Finished device change control <option value="Incorrect or no expiration date">Incorrect or no expiration date <option value="Labeling Change Control">Labeling Change Control <option value="Labeling False and Misleading">Labeling False and Misleading <option value="Labeling design">Labeling design <option value="Labeling mix-ups">Labeling mix-ups <option value="Manufacturing material removal">Manufacturing material removal <option value="Material/Component Contamination">Material/Component Contamination <option value="Mixed-up of materials/components">Mixed-up of materials/components <option value="No Marketing Application">No Marketing Application <option value="Nonconforming Material/Component">Nonconforming Material/Component <option value="Other">Other <option value="PMA">PMA <option value="Package design/selection">Package design/selection <option value="Packaging">Packaging <option value="Packaging change control">Packaging change control <option value="Packaging process control">Packaging process control <option value="Pending">Pending <option value="Process change control">Process change control <option value="Process control">Process control <option value="Process design">Process design <option value="Radiation Control for Health and Safety Act">Radiation Control for Health and Safety Act <option value="Release of Material/Component prior to receiving test results">Release of Material/Component prior to receiving test results <option value="Reprocessing Controls">Reprocessing Controls <option value="Software Design Change">Software Design Change <option value="Software Manufacturing/Software Deployment">Software Manufacturing/Software Deployment <option value="Software change control">Software change control <option value="Software design">Software design <option value="Software design (manufacturing process)">Software design (manufacturing process) <option value="Software in the Use Environment">Software in the Use Environment <option value="Storage">Storage <option value="Under Investigation by firm">Under Investigation by firm <option value="Unknown/Undetermined by firm">Unknown/Undetermined by firm <option value="Use error">Use error <option value="Vendor change control">Vendor change control </select> </td> </tr> <tr> <td style="font-weight:normal;"><label for="sortcolumn">Sort by</label></td> <td> <select name="sortcolumn" id="sortcolumn"> <option value="cdd" selected>Date Record Classified (Descending) <option value="cda">Date Record Classified (Ascending) <option value="idd">Date Action Initiated (Descending) <option value="ida">Date Action Initiated (Ascending) <option value="cca">Recall Class (1-3) <option value="ccd">Recall Class (3-1) <option value="lna">Recalling Manufacturer (A-Z) <option value="lnd">Recalling Manufacturer (Z-A) <option value="pda">Product Description (A-Z) <option value="pdd">Product Description (Z-A) </select> </td> </tr> <tr> <td align="center"> <a href="/scripts/cdrh/cfdocs/cfRes/textsearch.cfm" style="text-decoration:underline;">Quick Search</a>   </td> <td align="right"> <A style="text-decoration:underline;" href="javascript:doClear();" onfocus="window.status='Clear';return true;" onmouseover="window.status='Clear';return true;" onmouseout="window.status='';return true;">Clear Form</a>      <INPUT TYPE="submit" Name="Search" VALUE="Search">    </td> </tr> </table> </form> </div> </div> <div class="res-right"> <span style="font-weight: bold;">Other Databases</span> <ul style="margin:-5px;"> <li><a href="/scripts/cdrh/cfdocs/cfPMN/pmn.cfm" title="Database of new or significantly changed device information submitted by medical device manufacturers prior to commercial distribution.">510(k)s</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPMN/denovo.cfm" title="Database of De Novos.">De Novo</a></li> <li><a href="/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm" title="Reports of adverse events involving medical devices.">Medical Device Reports (MAUDE)</a></li> <li><a href="/scripts/cdrh/cfdocs/cfRL/DTLS/rl_cert.cfm" title="This searchable database contains valid export certificates submitted electronically via CECATS (CDRH Export Certification Application and Tracking System) and issued by the Center for Devices and Radiological Health.">CDRH Export Certificate Validation (CECV)</a></li> <li><a href="/scripts/cdrh/devicesatfda/readingroom.cfm" title="CDRH FOIA Electronic Reading Room.">CDRH FOIA Electronic Reading Room</a></li> <li><a href="/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm" title="Database of the most recent revision of Title 21 of the Code of Federal Regulations (CFR) from the Government Printing Office (GPO). ">CFR Title 21</a></li> <li><a href="/scripts/cdrh/cfdocs/cfClia/Search.cfm" title="Database of laboratory testing standards that ensure the accuracy, reliability and timeliness of patient tests.">CLIA</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPCD/classification.cfm" title="Database containing medical device names and associated information developed by the FDA Center for Devices and Radiological Health (CDRH) in support of its mission.">Device Classification</a></li> <li><a href="http://www.fda.gov/RegulatoryInformation/Guidances/default.htm" title="FDA Guidance Documents. ">FDA Guidance Documents </a></li> <li><a href="/scripts/cdrh/cfdocs/cfHDE/hde.cfm" title="Humanitaian Device Exemption (HDE) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. ">Humanitarian Device Exemption </a></li> <li><a href="/scripts/cdrh/cfdocs/Medsun/searchReportText.cfm" title="The Medical Product Safety Network (MedSun) improves FDA’s understanding of problems with the use of medical devices so that the FDA, healthcare facilities, clinicians, and manufacturers can better address safety concerns.">Medsun Reports</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPMA/pma.cfm" title="Database of Class III devices that support or sustain human life or are of substantial importance in preventing impairment of human health.">Premarket Approvals (PMAs)</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPMA/pma_pas.cfm" title="Database of Post-Approval Studies">Post-Approval Studies</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPMA/pss.cfm" title="Database of Postmarket Surveillance Studies">Postmarket Surveillance Studies</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPCD_RH/classification.cfm" title="The Radiation-Emitting Electronic Product Codes Database contains names of radiation-emitting electronic products and devices and associated information developed by the Center for Devices and Radiological Health (CDRH) in support of its mission. This database contains product names and their associated product codes. Additionally, the radiation type, definition, and applicable performance standards (21 CFR Parts 1020-1050) are provided.">Radiation-Emitting Products</a></li> <li><a href="/scripts/cdrh/cfdocs/cfPCD_RH/rh_res.cfm" title="Electronic products for which manufacturers are required to perform corrective actions when a radiation safety problem exists that was caused by the design, manufacturing, or assembly of the product.">Radiation-Emitting Electronic Products Corrective Actions</a></li> <li><a href="/scripts/cdrh/cfdocs/cfRL/rl.cfm" title="Database of devices in commercial distribution in the United States submitted by domestic and foreign manufacturers and medical device establishment information submitted by domestic and foreign establishments.">Registration & Listing</a></li> <li><a href="/scripts/cdrh/cfdocs/cfStandards/search.cfm" title="Database of Recognized Consensus Standards with associated FDA, medical device and standards industry information.">Standards</a></li> <li><a href="/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm" title="The Total Product Life Cycle (TPLC) database integrates premarket and postmarket data about medical devices. It includes information pulled from CDRH databases including Premarket Approvals (PMA), Premarket Notifications (510[k]), Adverse Events, and Recalls.">Total Product Life Cycle</a></li> <li><a href="/scripts/cdrh/cfdocs/cfAssem/assembler.cfm" title="Database of locations and identities of certified components of diagnostic x-ray systems for routine compliance testing at user facilities. 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