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MasterControl Study: FDA, CPSC Recalls Up 115% Since 2018 - Medical Design Briefs
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(Credit: Dzmitry/AdobeStock) MasterControl, a provider of quality and manufacturing software solutions for the life sciences industry, has released a new study analyzing five years of product recall data from the Food and Drug Administration (FDA) and Consumer Product Safety Commission (CPSC) showing that recalls have increased more than 115 percent since 2018."> <meta property="og:image" content="http://res.cloudinary.com/tbmg/ar_16:9,c_thumb,g_auto:subject,f_auto,q_auto/c_limit,w_400/v1713107485/sites/mdb/features-16x9/49736/adobestock_486356798_primary-feature-item.jpg"> <meta property="og:image:secure_url" content="https://res.cloudinary.com/tbmg/ar_16:9,c_thumb,g_auto:subject,f_auto,q_auto/c_limit,w_400/v1713107485/sites/mdb/features-16x9/49736/adobestock_486356798_primary-feature-item.jpg"> <meta property="og:url" content="https://www.medicaldesignbriefs.com/component/content/article/49736-new-mastercontrol-study-finds-recalls-up-115-since-2018"> <meta property="og:title" content="MasterControl Study: FDA, CPSC Recalls Up 115% Since 2018"> <meta property="og:type" content="article"> <meta property="og:locale" content="en_US"> <meta property="og:updated_time" content="2024-08-15 01:53:28"> <meta property="article:modified_time" content="2024-08-15 01:53:28"> <meta property="article:publisher" content="SAE Media Group"> <meta name="description" content="Product recall data from the Food and Drug Administration and Consumer Product Safety Commission show that recalls have increased more than 115 percent since 2018. (Credit: Dzmitry/AdobeStock) MasterControl, a provider of quality and manufacturing software solutions for the life sciences industry, has released a new study analyzing five years of product recall data from the Food and Drug Administration (FDA) and Consumer Product Safety Commission (CPSC) showing that recalls have increased more than 115 percent since 2018."> <title>MasterControl Study: FDA, CPSC Recalls Up 115% Since 2018 - Medical Design Briefs</title> <link href="https://www.medicaldesignbriefs.com/component/content/article/49736-new-mastercontrol-study-finds-recalls-up-115-since-2018" rel="canonical"> <style> /*! inlined from /media/plg_content_ntb_tagsbot/css/template.min.css by ntb_minifier */ .ntb_tagsbot .taglist { font-style: italic; margin-top: 10px } .ntb_tagsbot .tagmenus { background: #FFE; border: 1px dashed #DDD; padding: 10px; margin-bottom: 10px } .ntb_tagsbot .clusterlist { font-style: italic; margin-bottom: 10px; } .ntb_cluster_div { display: none; } .tagmenus 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var(--bs-nav-link-padding-x);font-size:var(--bs-nav-link-font-size);font-weight:var(--bs-nav-link-font-weight);color:var(--bs-nav-link-color)}.nav-fill .nav-item{flex:1 1 auto;text-align:center}.nav-fill .nav-item .nav-link{width:100%}.navbar{--bs-navbar-padding-x:0;--bs-navbar-padding-y:0.5rem;--bs-navbar-color:rgba(0, 0, 0, 0.55);--bs-navbar-hover-color:rgba(0, 0, 0, 0.7);--bs-navbar-disabled-color:rgba(0, 0, 0, 0.3);--bs-navbar-active-color:rgba(0, 0, 0, 0.9);--bs-navbar-brand-padding-y:0.25rem;--bs-navbar-brand-margin-end:1rem;--bs-navbar-brand-font-size:1.25rem;--bs-navbar-brand-color:rgba(0, 0, 0, 0.9);--bs-navbar-brand-hover-color:rgba(0, 0, 0, 0.9);--bs-navbar-nav-link-padding-x:0.5rem;--bs-navbar-toggler-padding-y:0.25rem;--bs-navbar-toggler-padding-x:0.75rem;--bs-navbar-toggler-font-size:1.25rem;--bs-navbar-toggler-icon-bg:url("data:image/svg+xml,%3csvg xmlns='http://www.w3.org/2000/svg' viewBox='0 0 30 30'%3e%3cpath stroke='rgba%280, 0, 0, 0.55%29' stroke-linecap='round' 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var(--bs-navbar-padding-x);background-image:var(--bs-gradient)}.navbar>.container,.navbar>.container-fluid{display:flex;flex-wrap:inherit;align-items:center;justify-content:space-between}.navbar-brand{padding-top:var(--bs-navbar-brand-padding-y);padding-bottom:var(--bs-navbar-brand-padding-y);margin-right:var(--bs-navbar-brand-margin-end);font-size:var(--bs-navbar-brand-font-size);color:var(--bs-navbar-brand-color);white-space:nowrap}.navbar-nav{--bs-nav-link-padding-x:0;--bs-nav-link-padding-y:0.7rem;--bs-nav-link-color:var(--bs-navbar-color);--bs-nav-link-hover-color:var(--bs-navbar-hover-color);--bs-nav-link-disabled-color:var(--bs-navbar-disabled-color);display:flex;flex-direction:column;padding-left:0;margin-bottom:0;list-style:none}.navbar-collapse{flex-basis:100%;flex-grow:1;align-items:center}.navbar-toggler{padding:var(--bs-navbar-toggler-padding-y) var(--bs-navbar-toggler-padding-x);font-size:var(--bs-navbar-toggler-font-size);line-height:1;color:var(--bs-navbar-color);background-color:transparent;border:var(--bs-border-width) solid var(--bs-navbar-toggler-border-color);border-radius:var(--bs-navbar-toggler-border-radius)}@media (min-width:576px){.navbar-expand-sm{flex-wrap:nowrap;justify-content:flex-start}.navbar-expand-sm .navbar-nav{flex-direction:row}.navbar-expand-sm .navbar-nav .nav-link{padding-right:var(--bs-navbar-nav-link-padding-x);padding-left:var(--bs-navbar-nav-link-padding-x)}.navbar-expand-sm .navbar-collapse{display:flex!important;flex-basis:auto}.navbar-expand-sm .navbar-toggler{display:none}}body:before{display:none}.navbar-dark{--bs-navbar-color:#324a98;--bs-navbar-hover-color:#4d4d4f;--bs-navbar-disabled-color:rgba(255, 255, 255, 0.25);--bs-navbar-active-color:#324a98;--bs-navbar-brand-color:#324a98;--bs-navbar-brand-hover-color:#324a98;--bs-navbar-toggler-border-color:transparent;--bs-navbar-toggler-icon-bg:none}.card{--bs-card-spacer-y:1rem;--bs-card-spacer-x:1rem;--bs-card-title-spacer-y:0.5rem;--bs-card-border-width:1px;--bs-card-border-color:var(--bs-border-color-translucent);--bs-card-border-radius:0.375rem;--bs-card-inner-border-radius:calc(0.375rem - 1px);--bs-card-cap-padding-y:0.5rem;--bs-card-cap-padding-x:1rem;--bs-card-cap-bg:rgba(0, 0, 0, 0.03);--bs-card-bg:#f8f9fa;--bs-card-img-overlay-padding:1rem;--bs-card-group-margin:0.75rem;position:relative;display:flex;flex-direction:column;min-width:0;height:var(--bs-card-height);word-wrap:break-word;background-color:var(--bs-card-bg);background-clip:border-box;border:var(--bs-card-border-width) solid var(--bs-card-border-color);border-radius:var(--bs-card-border-radius);box-shadow:var(--bs-card-box-shadow)}.card-body{flex:1 1 auto;padding:var(--bs-card-spacer-y) var(--bs-card-spacer-x);color:var(--bs-card-color)}.breadcrumb{display:flex;list-style:none;--bs-breadcrumb-padding-x:0;--bs-breadcrumb-padding-y:0.5rem;--bs-breadcrumb-margin-bottom:0;--bs-breadcrumb-font-size:0.75rem;--bs-breadcrumb-bg:transparent;--bs-breadcrumb-divider-color:#6c757d;--bs-breadcrumb-item-padding-x:0.5rem;--bs-breadcrumb-item-active-color:#6c757d;flex-wrap:wrap;padding:var(--bs-breadcrumb-padding-y) var(--bs-breadcrumb-padding-x);margin-bottom:var(--bs-breadcrumb-margin-bottom);font-size:var(--bs-breadcrumb-font-size);background-color:var(--bs-breadcrumb-bg);border-radius:var(--bs-breadcrumb-border-radius)}.breadcrumb-item+.breadcrumb-item{padding-left:var(--bs-breadcrumb-item-padding-x)}.breadcrumb-item+.breadcrumb-item::before{float:left;padding-right:var(--bs-breadcrumb-item-padding-x);color:var(--bs-breadcrumb-divider-color);content:var(--bs-breadcrumb-divider, "|")}.breadcrumb-item.active{color:var(--bs-breadcrumb-item-active-color)}.alert{--bs-alert-bg:transparent;--bs-alert-padding-x:1rem;--bs-alert-padding-y:1rem;--bs-alert-margin-bottom:1rem;--bs-alert-color:inherit;--bs-alert-border-color:transparent;--bs-alert-border:1px solid var(--bs-alert-border-color);--bs-alert-border-radius:0.375rem;position:relative;padding:var(--bs-alert-padding-y) var(--bs-alert-padding-x);margin-bottom:var(--bs-alert-margin-bottom);color:var(--bs-alert-color);background-color:var(--bs-alert-bg);border:var(--bs-alert-border);border-radius:var(--bs-alert-border-radius)}.alert-heading{color:inherit}.alert-link{font-weight:700}.alert-dismissible{padding-right:3rem}.alert-dismissible .btn-close{position:absolute;top:0;right:0;z-index:2;padding:1.25rem 1rem}.alert-primary,.alert-secondary{background-image:var(--bs-gradient)}.alert-primary{--bs-alert-color:rgb(30, 44.4, 91.2);--bs-alert-bg:rgb(214, 218.8, 234.4);--bs-alert-border-color:rgb(193.5, 200.7, 224.1)}.alert-primary .alert-link{color:#182449}.alert-secondary{--bs-alert-color:rgb(64.8, 70.2, 75);--bs-alert-bg:rgb(225.6, 227.4, 229);--bs-alert-border-color:rgb(210.9, 213.6, 216)}.alert-secondary .alert-link{color:#34383c}.alert-native,.alert-success,.alert-validation{--bs-alert-color:rgb(15, 81, 50.4);--bs-alert-bg:rgb(209, 231, 220.8);--bs-alert-border-color:rgb(186, 219, 203.7);background-image:var(--bs-gradient)}.alert-native .alert-link,.alert-success .alert-link,.alert-validation .alert-link{color:#0c4128}.alert-info,.alert-warning{background-image:var(--bs-gradient)}.alert-info{--bs-alert-color:rgb(5.2, 80.8, 96);--bs-alert-bg:rgb(206.6, 244.4, 252);--bs-alert-border-color:rgb(182.4, 239.1, 250.5)}.alert-info .alert-link{color:#04414d}.alert-warning{--bs-alert-color:rgb(102, 77.2, 2.8);--bs-alert-bg:rgb(255, 242.6, 205.4);--bs-alert-border-color:rgb(255, 236.4, 180.6)}.alert-warning .alert-link{color:#523e02}.alert-danger,.alert-error{--bs-alert-color:#8a0000;--bs-alert-bg:#facccc;--bs-alert-border-color:rgb(247.5, 178.5, 178.5);background-image:var(--bs-gradient)}.alert-danger .alert-link,.alert-error .alert-link{color:#6e0000}.alert-light{--bs-alert-color:rgb(99.2, 99.6, 100);--bs-alert-bg:rgb(253.6, 253.8, 254);--bs-alert-border-color:rgb(252.9, 253.2, 253.5);background-image:var(--bs-gradient)}.alert-light .alert-link{color:#4f5050}.alert-cleanup,.alert-dark{--bs-alert-color:rgb(19.8, 22.2, 24.6);--bs-alert-bg:rgb(210.6, 211.4, 212.2);--bs-alert-border-color:rgb(188.4, 189.6, 190.8);background-image:var(--bs-gradient)}.alert-cleanup .alert-link,.alert-dark .alert-link{color:#101214}.alert-inverse{--bs-alert-color:#666666;--bs-alert-bg:white;--bs-alert-border-color:white}.alert-inverse .alert-link{color:#525252}.alert-inverse,.alert-navbar,.alert-navitem{background-image:var(--bs-gradient)}.alert-navbar{--bs-alert-color:rgb(87.2, 88, 88.8);--bs-alert-bg:rgb(247.6, 248, 248.4);--bs-alert-border-color:rgb(243.9, 244.5, 245.1)}.alert-navbar .alert-link{color:#464647}.alert-navitem{--bs-alert-color:#666666;--bs-alert-bg:white;--bs-alert-border-color:white}.alert-navitem .alert-link{color:#525252}.alert-lightgray{--bs-alert-color:rgb(93.2, 94.4, 95.6);--bs-alert-bg:rgb(250.6, 251.2, 251.8);--bs-alert-border-color:rgb(248.4, 249.3, 250.2)}.alert-lightgray .alert-link{color:#4b4c4c}.alert-color-indigo,.alert-lightgray{background-image:var(--bs-gradient)}.alert-advertising,.alert-color-indigo{--bs-alert-color:rgb(61.2, 9.6, 145.2);--bs-alert-bg:rgb(224.4, 207.2, 252.4);--bs-alert-border-color:rgb(209.1, 183.3, 251.1)}.alert-color-indigo .alert-link{color:#310874}.alert-color-cyan{--bs-alert-color:rgb(5.2, 80.8, 96);--bs-alert-bg:rgb(206.6, 244.4, 252);--bs-alert-border-color:rgb(182.4, 239.1, 250.5);background-image:var(--bs-gradient)}.alert-color-cyan .alert-link{color:#04414d}.alert-color-blue,.alert-criticalcss{--bs-alert-color:rgb(7.8, 66, 151.8);--bs-alert-bg:rgb(206.6, 226, 254.6);--bs-alert-border-color:rgb(182.4, 211.5, 254.4);background-image:var(--bs-gradient)}.alert-color-blue .alert-link,.alert-criticalcss .alert-link{color:#063579}.alert-color-orange{background-image:var(--bs-gradient)}.alert-cache,.alert-color-orange{--bs-alert-color:rgb(151.8, 75.6, 12);--bs-alert-bg:rgb(254.6, 229.2, 208);--bs-alert-border-color:rgb(254.4, 216.3, 184.5)}.alert-color-orange .alert-link{color:#793c0a}.alert-color-red{--bs-alert-color:rgb(132, 31.8, 41.4);--bs-alert-bg:rgb(248, 214.6, 217.8);--bs-alert-border-color:rgb(244.5, 194.4, 199.2);background-image:var(--bs-gradient)}.alert-color-red .alert-link{color:#6a1921}.alert-cdnjs,.alert-color-yellow{--bs-alert-color:rgb(102, 77.2, 2.8);--bs-alert-bg:rgb(255, 242.6, 205.4);--bs-alert-border-color:rgb(255, 236.4, 180.6)}.alert-cdnjs .alert-link,.alert-color-yellow .alert-link{color:#523e02}.alert-cdnjs,.alert-color-teal,.alert-color-yellow{background-image:var(--bs-gradient)}.alert-color-teal,.alert-topic{--bs-alert-color:rgb(19.2, 120.6, 90.6);--bs-alert-bg:rgb(210.4, 244.2, 234.2);--bs-alert-border-color:rgb(188.1, 238.8, 223.8)}.alert-color-teal .alert-link{color:#0f6048}.alert-color-green{--bs-alert-color:rgb(15, 81, 50.4);--bs-alert-bg:rgb(209, 231, 220.8);--bs-alert-border-color:rgb(186, 219, 203.7);background-image:var(--bs-gradient)}.alert-color-green .alert-link{color:#0c4128}.alert-cloudinary,.alert-color-pink{--bs-alert-color:rgb(128.4, 30.6, 79.2);--bs-alert-bg:rgb(246.8, 214.2, 230.4);--bs-alert-border-color:rgb(242.7, 193.8, 218.1);background-image:var(--bs-gradient)}.alert-cloudinary .alert-link,.alert-color-pink .alert-link{color:#67183f}.alert-color-black{--bs-alert-color:black;--bs-alert-bg:#cccccc;--bs-alert-border-color:rgb(178.5, 178.5, 178.5);background-image:var(--bs-gradient)}.alert-color-black .alert-link{color:#000}.alert-color-white{--bs-alert-color:#666666;--bs-alert-bg:white;--bs-alert-border-color:white;background-image:var(--bs-gradient)}.alert-color-white .alert-link{color:#525252}.alert-color-gray{--bs-alert-color:rgb(64.8, 70.2, 75);--bs-alert-bg:rgb(225.6, 227.4, 229);--bs-alert-border-color:rgb(210.9, 213.6, 216);background-image:var(--bs-gradient)}.alert-color-gray .alert-link{color:#34383c}.alert-color-gray-dark{--bs-alert-color:rgb(31.2, 34.8, 38.4);--bs-alert-bg:rgb(214.4, 215.6, 216.8);--bs-alert-border-color:rgb(194.1, 195.9, 197.7);background-image:var(--bs-gradient)}.alert-color-gray-dark .alert-link{color:#191c1f}.alert-cache{--bs-alert-color:rgb(61.2, 9.6, 145.2);--bs-alert-bg:rgb(224.4, 207.2, 252.4);--bs-alert-border-color:rgb(209.1, 183.3, 251.1);background-image:var(--bs-gradient)}.alert-cache .alert-link{color:#310874}.alert-notice{--bs-alert-color:rgb(5.2, 80.8, 96);--bs-alert-bg:rgb(206.6, 244.4, 252);--bs-alert-border-color:rgb(182.4, 239.1, 250.5)}.alert-notice .alert-link{color:#04414d}.alert-advertising,.alert-notice,.alert-topic{background-image:var(--bs-gradient)}.alert-topic{--bs-alert-color:rgb(113.4, 34.2, 10.2);--bs-alert-bg:rgb(241.8, 215.4, 207.4);--bs-alert-border-color:rgb(235.2, 195.6, 183.6)}.alert-topic .alert-link{color:#5b1b08}.alert-advertising{--bs-alert-color:rgb(102, 77.2, 2.8);--bs-alert-bg:rgb(255, 242.6, 205.4);--bs-alert-border-color:rgb(255, 236.4, 180.6)}.alert-advertising .alert-link{color:#523e02}.list-group{--bs-list-group-color:#212529;--bs-list-group-bg:#fff;--bs-list-group-border-color:rgba(0, 0, 0, 0.125);--bs-list-group-border-width:1px;--bs-list-group-border-radius:0.375rem;--bs-list-group-item-padding-x:1rem;--bs-list-group-item-padding-y:0.5rem;--bs-list-group-action-color:#495057;--bs-list-group-action-hover-color:#495057;--bs-list-group-action-hover-bg:#f8f9fa;--bs-list-group-action-active-color:#212529;--bs-list-group-action-active-bg:#e9ecef;--bs-list-group-disabled-color:#6c757d;--bs-list-group-disabled-bg:#fff;--bs-list-group-active-color:#fff;--bs-list-group-active-bg:#bd3911;--bs-list-group-active-border-color:#bd3911;display:flex;flex-direction:column;padding-left:0;margin-bottom:0;border-radius:var(--bs-list-group-border-radius)}.list-group-item{position:relative;display:block;padding:var(--bs-list-group-item-padding-y) var(--bs-list-group-item-padding-x);color:var(--bs-list-group-color);background-color:var(--bs-list-group-bg);border:var(--bs-list-group-border-width) solid var(--bs-list-group-border-color)}.list-group-item:first-child{border-top-left-radius:inherit;border-top-right-radius:inherit}.list-group-item:last-child{border-bottom-right-radius:inherit;border-bottom-left-radius:inherit}.list-group-item+.list-group-item{border-top-width:0}.btn-close{box-sizing:content-box;width:1em;height:1em;padding:.25em;color:#000;background:url("data:image/svg+xml,%3csvg xmlns='http://www.w3.org/2000/svg' viewBox='0 0 16 16' fill='%23000'%3e%3cpath d='M.293.293a1 1 0 0 1 1.414 0L8 6.586 14.293.293a1 1 0 1 1 1.414 1.414L9.414 8l6.293 6.293a1 1 0 0 1-1.414 1.414L8 9.414l-6.293 6.293a1 1 0 0 1-1.414-1.414L6.586 8 .293 1.707a1 1 0 0 1 0-1.414z'/%3e%3c/svg%3e") center/1em auto no-repeat;border:0;border-radius:.375rem;opacity:.5}.modal{--bs-modal-zindex:1055;--bs-modal-width:500px;--bs-modal-padding:1rem;--bs-modal-margin:0.5rem;--bs-modal-bg:#fff;--bs-modal-border-color:var(--bs-border-color-translucent);--bs-modal-border-width:1px;--bs-modal-border-radius:0.5rem;--bs-modal-box-shadow:0 0.125rem 0.25rem rgba(0, 0, 0, 0.075);--bs-modal-inner-border-radius:calc(0.5rem - 1px);--bs-modal-header-padding-x:1rem;--bs-modal-header-padding-y:1rem;--bs-modal-header-padding:1rem 1rem;--bs-modal-header-border-color:var(--bs-border-color);--bs-modal-header-border-width:1px;--bs-modal-title-line-height:1.5;--bs-modal-footer-gap:0.5rem;--bs-modal-footer-border-color:var(--bs-border-color);--bs-modal-footer-border-width:1px;position:fixed;top:0;left:0;z-index:var(--bs-modal-zindex);display:none;width:100%;height:100%;overflow-x:hidden;overflow-y:auto;outline:0}.modal-dialog{position:relative;width:auto;margin:var(--bs-modal-margin)}.modal.fade .modal-dialog{transform:translate(0,-50px)}.modal-content{position:relative;display:flex;flex-direction:column;width:100%;color:var(--bs-modal-color);background-color:var(--bs-modal-bg);background-clip:padding-box;border:var(--bs-modal-border-width) solid var(--bs-modal-border-color);border-radius:var(--bs-modal-border-radius);box-shadow:var(--bs-modal-box-shadow);outline:0}.modal-header{display:flex;flex-shrink:0;align-items:center;justify-content:space-between;padding:var(--bs-modal-header-padding);border-bottom:var(--bs-modal-header-border-width) solid var(--bs-modal-header-border-color);border-top-left-radius:var(--bs-modal-inner-border-radius);border-top-right-radius:var(--bs-modal-inner-border-radius)}.modal-title{margin-bottom:0;line-height:var(--bs-modal-title-line-height)}.modal-body{position:relative;flex:1 1 auto;padding:var(--bs-modal-padding)}@media (min-width:576px){.modal{--bs-modal-margin:1.75rem;--bs-modal-box-shadow:0 0.5rem 1rem rgba(0, 0, 0, 0.15)}.modal-dialog{max-width:var(--bs-modal-width);margin-right:auto;margin-left:auto}.modal-sm{--bs-modal-width:300px}}.offcanvas{--bs-offcanvas-zindex:1045;--bs-offcanvas-width:400px;--bs-offcanvas-height:30vh;--bs-offcanvas-padding-x:1rem;--bs-offcanvas-padding-y:1rem;--bs-offcanvas-bg:#fff;--bs-offcanvas-border-width:1px;--bs-offcanvas-border-color:var(--bs-border-color-translucent);--bs-offcanvas-box-shadow:0 0.125rem 0.25rem rgba(0, 0, 0, 0.075);position:fixed;bottom:0;z-index:var(--bs-offcanvas-zindex);display:flex;flex-direction:column;max-width:100%;color:var(--bs-offcanvas-color);visibility:hidden;background-color:var(--bs-offcanvas-bg);background-clip:padding-box;outline:0;box-shadow:var(--bs-offcanvas-box-shadow)}.offcanvas.offcanvas-start{top:0;left:0;width:var(--bs-offcanvas-width);border-right:var(--bs-offcanvas-border-width) solid 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data-src='https://res.cloudinary.com/tbmg/c_scale,w_auto,f_auto,q_auto/v1713107283/sites/mdb/articles/2023/news/AdobeStock_486356798.jpg' class=' w-100 cld-responsive' alt='' /></p> <figcaption>Product recall data from the Food and Drug Administration and Consumer Product Safety Commission show that recalls have increased more than 115 percent since 2018. (Credit: Dzmitry/AdobeStock)</figcaption></figure> <p> <a href="https://www.mastercontrol.com/" target="_blank" rel="noopener" rel="noopener noreferrer">MasterControl <i class="fad fa-external-link fa-sm"></i></a> , a provider of quality and manufacturing software solutions for the life sciences industry, has released a new study analyzing five years of product recall data from the Food and Drug Administration (FDA) and Consumer Product Safety Commission (CPSC) showing that recalls have increased more than 115 percent since 2018.</p> <p>“The first step in creating change is understanding what issues to focus on which is what we hope this data provides. We’re seeing that there are problem areas like allergens and categories like infant products that get flagged frequently,” says Matt Lowe, chief strategy officer (CSO) at MasterControl. “This analysis is meant to surface the areas where companies can improve and highlight the crucial need to maintain accurate records and implement more stringent controls that prioritize transparency and accountability in all aspects of their operations.”</p> <h3>The Culprits</h3> <p>Recalls have hit five-year highs with more than 600 in 2022 alone. Agencies have increased regulatory oversight in the last few years which is a likely reason for the increase, but a dive into the data helps uncover what they are seeing.</p> <ul> <li>Allergens have driven the largest number of recalls (34 percent) from the FDA over the last five years while fire hazards caused the CPSC to pull the most items (24 percent) from the market.</li> <li>Foods with undeclared or mislabeled allergens were recalled 1.6 times more often than foods recalled for foodborne illness.</li> <li>More than 1 in 5 FDA recalls since 2018 were driven by process and contamination concerns.</li></ul> <h3>Headlines or Hype</h3><div class="ad-position g-0 row mb-3 "> <div class="col-12 align-content-center mx-auto"> <script tb-donotmove>window.ntb_google_ad_manager_items=window.ntb_google_ad_manager_items||[];ntb_google_ad_manager_items.push({display_sizes:['xs','sm'],slot_ad_unit:'medicaldesignbriefs.com_450x450_300x300',slot_code:'21835072403',slot:'/21835072403/medicaldesignbriefs.com_450x450_300x300',slot_ad_sizes:['fluid',[450,450],[300,300]],div_id:'GAM_pos_22_modid_421',target_pos:'22',size_mapping:[],slot_ad_empty:'default'});</script> <div id='GAM_pos_22_modid_421' class=""></div></div></div><p>These quality culprits rear their head in some categories more than others. Recent headlines on salmonella in dog food and return requests for baby formula point to where issues hit the most—products and food for kids and pets. Other shocking headlines have called out medical device manufacturers for faulty pacemakers and more, but the data tells the true story on recall frequency here.</p> <ul> <li>Kid safety is the leading cause of recalls for the CPSC, with more than 1 in 5 involving child and baby products — more than any other category.</li> <li>There were twice as many recalls on pet food and animal products in the past five years than those issued on baby formula.</li> <li>Only 4 percent of FDA recalls were for medical devices since 2018.</li> <li>While manufacturers are making progress in many areas, still nearly a third (30 percent) of FDA recalls pertain to quality management, and the majority (62 percent) of CPSC recalls were made only after injury or incident involving the product were reported.</li></ul> <p>“Companies have to do better prioritizing quality management before they injure or impact the customer. The increase in the number of recalls since 2018 highlights the vital importance of prioritizing quality and safety tracking across life science and consumer industries,” Lowe says. “Careful leaders will see that regulators have a closer eye on quality in the manufacturing process than ever before and these changes will require organizations to see quality assurance, not just as a cost center, but as a strategic priority for business.”</p> <p>Click <a href="https://www.mastercontrol.com/gxp-lifeline/rise-in-product-recalls-impact-on-quality-management" target="_blank" rel="noopener" rel="noopener noreferrer">here <i class="fad fa-external-link fa-sm"></i></a> to read the full <a href="https://www.mastercontrol.com/gxp-lifeline/rise-in-product-recalls-impact-on-quality-management" target="_blank" rel="noopener" rel="noopener noreferrer">MasterControl 2023 Recall Report <i class="fad fa-external-link fa-sm"></i></a> .</p> <h3>Methodology</h3> <p>MasterControl commissioned Method Research to examine publicly available data about recalls in the U.S. from the FDA and Consumer Product Safety Commission. The team examined data from <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts" target="_blank" rel="noopener noreferrer">https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts <i class="fad fa-external-link fa-sm"></i></a> and <a href="https://www.cpsc.gov/Recalls" target="_blank" rel="noopener noreferrer">https://www.cpsc.gov/Recalls <i class="fad fa-external-link fa-sm"></i></a> with the date range of January 1, 2018 to September 31, 2023 accessed between September 25, 2023 and October 5, 2023.</p> <hr> <div class="ntb_tagsbot"> <div class="taglist"> <strong class="sans-serif text-small">Topics:</strong><br> <a class="badge bg-primary link-white fw-light sans-serif text-small fst-normal" href="/component/ntb_tags/topic/regulations-standards/fda_compliance_regulatory_affairs/mdb/*?start=0"> <i class="fa-duotone fa-user-police"></i> FDA Compliance/Regulatory Affairs</a> <a class="badge bg-primary link-white fw-light sans-serif text-small 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src='https://res.cloudinary.com/tbmg/ar_16:9,c_thumb,g_auto:subject,f_auto,q_auto/c_limit,w_100/v1729889294/sites/mdb/features-16x9/51891/102524-mdb-quiz_adobe_primary-feature-item.jpg' class='w-100 lazyload blur-up' width='100' height='45' alt='Feature Image' /></a></div> <i class="fa-duotone fa-solid fa-newspaper me-1"></i> Quiz: Mechanical & Fluid Systems</h6> <p class="story-min-height mt-1"> <a class="topstories_module_link" href="/component/content/article/51891-what-do-you-know-about-medtech-and-the-gridiron" alt="What Do You Know About Medtech and the Gridiron?"> What Do You Know About Medtech and the Gridiron?</a></p></div></div></div> <div class="row mb-3 "> <div class="col-12"> <h4 class="section-overline">Ask the Expert</h4> <div class="ntb-asktheexpert"> <h6>John Chandler on Achieving Quality Motion Control</h6> <img src='https://res.cloudinary.com/tbmg/ar_3:4,c_thumb,g_auto:subject,f_auto,q_auto/c_limit,w_200/v1605127074/sites/mdb/articles/2020/sponsored/asktheexpert/john_chandler.jpg' class='float-start w-33 me-2 mb-1 lazyload blur-up' width='200' alt='Feature Image' /><p>FAULHABER MICROMO brings together the highest quality motion technologies and value-added services, together with global engineering, sourcing, and manufacturing, to deliver top quality micro motion solutions. With 34 years’ experience, John Chandler injects a key engineering perspective into all new projects and enjoys working closely with OEM customers to bring exciting new technologies to market.</p> <a href="/component/content/article/38040-ask-the-expert-john-chandler-on-achieving-quality-motion-control"> <button class="btn btn-primary text-uppercase"> Read More <i class="fas fa-angle-right"></i> </button> </a></div></div></div> <div class="ad-position g-0 row mb-3 "> <div class="col-12 align-content-center mx-auto"> <script tb-donotmove>window.ntb_google_ad_manager_items=window.ntb_google_ad_manager_items||[];ntb_google_ad_manager_items.push({display_sizes:['md','lg','xl','xxl'],slot_ad_unit:'medicaldesignbriefs.com_450x450_300x300',slot_code:'21835072403',slot:'/21835072403/medicaldesignbriefs.com_450x450_300x300',slot_ad_sizes:['fluid',[450,450],[300,300]],div_id:'GAM_pos_23_modid_415',target_pos:'23',size_mapping:[],slot_ad_empty:'default'});</script> <div id='GAM_pos_23_modid_415' class=""></div></div></div> <div class="row mb-3 "> <div class="col-12"> <h4 class="section-overline">Inside Story</h4> <div class="ntb-asktheexpert"> <h6>Inside Story: Establishing Safe EO Residual Levels for Medical Devices</h6> <img src='https://res.cloudinary.com/tbmg/ar_3:4,c_thumb,g_auto:subject,f_auto,q_auto/c_limit,w_200/v1705772502/sites/mdb/articles/2023/features/MDB-0123-insidestory-fig1.jpg' class='float-start w-33 me-2 mb-1 lazyload blur-up' width='200' alt='Feature Image' /><p>To find out more about the expertise required to establish safe EO Residual levels for medical devices, Medical Design Briefs recently spoke with Leonard Harris, Manager, Chemistry and Container Testing for Eurofins Medical Device Testing (Lancaster, PA).</p> <a href="/component/content/article/49693-inside-story-mdb-0123"> <button class="btn btn-primary text-uppercase"> Read More <i class="fas fa-angle-right"></i> </button> </a></div></div></div> <div class="ad-position g-0 row mb-3 "> <div 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lazyload blur-up' width='100' height='45' alt='Feature Image' /></div> <i class="fa-duotone fa-solid fa-bullhorn me-1"></i> Upcoming Webinars: Electronics & Computers</h6> <p class="story-min-height mt-1"> <a class="webinar_module_link" href="/component/content/article/51616-a-guide-to-selecting-power-supplies-for-medical-equipment"> A Guide to Selecting Power Supplies for Medical Equipment</a></p> <h6 class="overline"> <div class="float-end d-xl-block ms-1 d-none" style="width:80px"> <img src='https://res.cloudinary.com/tbmg/ar_16:9,c_thumb,g_auto:subject,f_auto,q_auto/c_limit,w_100/v1730288828/sites/mdb/features-16x9/51806/cpc-benefits-of-streamlining_primary-feature-item.jpg' class='w-100 lazyload blur-up' width='100' height='45' alt='Feature Image' /></div> <i class="fa-duotone fa-solid fa-bullhorn me-1"></i> On-Demand Webinars: Medical</h6> <p class="story-min-height mt-1"> <a class="webinar_module_link" href="/component/content/article/51806-benefits-of-streamlining-fluid-connections-in-medical-applications"> Benefits of Streamlining Fluid Connections in Medical Applications</a></p> <h6 class="overline"> <div class="float-end d-xl-block ms-1 d-none" style="width:80px"> <img src='https://res.cloudinary.com/tbmg/ar_16:9,c_thumb,g_auto:subject,f_auto,q_auto/c_limit,w_100/v1729692857/sites/mdb/features-16x9/51665/shutterstock_649070965_primary-feature-item.jpg' class='w-100 lazyload blur-up' width='100' height='45' alt='Feature Image' /></div> <i class="fa-duotone fa-solid fa-bullhorn me-1"></i> On-Demand Webinars: Materials</h6> <p class="story-min-height mt-1"> <a class="webinar_module_link" href="/component/content/article/51665-the-power-of-the-wear-study-in-medical-device-development"> The Power of the Wear Study in Medical Device Development</a></p> <h6 class="overline"> <div class="float-end d-xl-block ms-1 d-none" style="width:80px"> <img 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Webinars: Wearables</h6> <p class="story-min-height mt-1"> <a class="webinar_module_link" href="/component/content/article/51868-addressing-connectivity-and-performance-in-connected-care-iot-devices"> Addressing Connectivity and Performance in Connected Care IoT Devices</a></p> <h6 class="overline"> <div class="float-end d-xl-block ms-1 d-none" style="width:80px"> <img src='https://res.cloudinary.com/tbmg/ar_16:9,c_thumb,g_auto:subject,f_auto,q_auto/c_limit,w_100/v1729273236/sites/mdb/features-16x9/51853/102224-mdb-podcast_trends_primary-feature-item.jpg' class='w-100 lazyload blur-up' width='100' height='45' alt='Feature Image' /></div> <i class="fa-duotone fa-solid fa-podcast me-1"></i> Podcasts: Design</h6> <p class="story-min-height mt-1"> <a class="webinar_module_link" href="/component/content/article/51853-emerging-trends-in-drug-delivery"> Emerging Trends in Drug Delivery</a></p></div></div></div> <div class="ad-position g-0 row mb-3 "> <div class="col-12 align-content-center 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