Navigation Links
Medical Device Recalls Reach Five-Quarter High in ExpertRECALL Index

INDIANAPOLIS, Aug. 19, 2013 /PRNewswire/ -- According to the ExpertRECALL Index released today, 48 percent of all medical device recalls reported in the second quarter of 2013 had both U.S. and international components. In addition, the number of device recalls increased 30 percent from the last quarter, resulting in the highest number of recalls in the last five quarters. With medical device recalls increasing and occurring more frequently on a global scale, manufacturers must be capable of performing a global recall and be knowledgeable of all the regulatory environments within the countries they operate.

"Scalability will be critical for medical device manufacturers facing product recalls going forward, and it's one of the reasons why ExpertRECALL has recently expanded its global capabilities," said Rozembajgier. "Safety in global distribution and supply chains has no boundaries. Companies should implement recall plans that prepare for the increased complication and regulatory oversight that they or their vendors will have to navigate during an international product recall."

Recalls from compounding pharmacies also continue to be a prominent source of pharmaceutical recalls according to the Index. In the second quarter, two compounding pharmacies accounted for 104 recall events, more than 43 percent of all pharmaceutical recalls reported for the quarter. Because of these serious events and the resulting media attention, the FDA has significantly increased its inspections of compounding pharmacies. In addition, the Government Accountability Office (GAO) recently recommended that the FDA be granted greater oversight and regulatory control of compounding pharmacies.

"Compounding pharmacies continue to face multiple events a quarter, which has attracted a lot of regulatory attention. It is more important than ever for these manufacturers to be vigilant and pay close attention to current safety compliance programs and best recall preparedness practices," Rozembajgier continued. "It is no longer a matter of if the FDA shows up at their door, it is when."

In the food industry, recalls due to undeclared allergens continue to plague manufacturers. Sixty-five percent of recalls from the United States Department of Agriculture (USDA) in the second quarter of 2013 were the result of an undeclared allergen. The trend is also reflected in recalls by the United States Food and Drug Administration (FDA), with 60 percent of recalls documented on its website occurring due to undeclared allergens, up from 34 percent in the previous quarter. Undeclared allergens have consistently been a top trend for USDA and FDA recalls for the past several quarters.

"Allergens continue to be a top recall trend that we see quarter over quarter," said Mike Rozembajgier, vice president of Stericycle ExpertRECALL. "Food manufacturers should make sure that they are reviewing labels and formulations related to their company's Allergen Control Program before an inspector arrives onsite."

The Consumer Product Safety Commission (CPSC) reported 71 recalls this quarter, the second-lowest number in the past six quarters. However, the CPSC also issued a mandatory recall of a children's toy product, an action that has only occurred four times in the past 11 years. Because of this, 52 percent of all CPSC recalled units came from one recall in the children's and infant category.

The 2013 second quarter ExpertRECALL Index is the only report that aggregates and tracks cumulative recall data from the U.S. Consumer Product Safety Commission (CPSC), the FDA and the USDA. The ExpertRECALL Index report is available online at

About Stericycle ExpertRECALL™
Stericycle ExpertRECALL™ is the global industry leader in managing consumer product, food and beverage, pharmaceutical, medical device and juvenile product recalls. Stericycle ExpertRECALL streamlines the entire product recall process and manages Notification & Response, Processing & Tracking, and Compliance & Reporting for a variety of companies. For more information, visit

Andy Stuckey
Media Manager


SOURCE Stericycle ExpertRECALL
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. ParagonRx, An inVentiv Health Company, Names Former U.S. Food And Drug Administration Official To Position Of Chief Medical Officer
2. Device Sector Facing Medical Education Challenges as Industry Continues Expansion into Emerging Markets
3. Ann Arbor Digital Devices debuts the first ever digital motion x-ray image capturing device for conventional medical x-ray installations
4. Concord Medical Announces Acquisition of Its Shares by CEO and COO from Other Shareholders
5. Maldonado Medical Defies National Unemployment Rate with Consistent Hiring
6. BSI Offers Medical Device Manufacturers Exclusive Access to Global Panel of Experts in 3 Key Cities
7. Medical Laser Expert Robert E. Grove, PhD Appointed To Ellman International Board of Directors
8. Frost & Sullivan Recognizes Nonin Medical with 2013 North American Pulse Oximetry Devices Product Quality Leadership Award
9. Vasomedical Announces Financial Results for the Second Quarter of 2013
10. Medical Marijuana Company Celebrates 3rd Anniversary with "Weed" hosted by Dr. Sanja Gupta on CNN
11. Senator Shares Insight on Florida Physician Dispensing Legislation as First Guest of Progressive Medicals New SignatureSeries
Post Your Comments:
(Date:11/26/2015)... 2015 ) ... "Radioimmunoassay Market by Type (Reagents & Kits, ... Clinical Diagnostic Labs), Application (Research, Clinical Diagnostics), ... report to their offering. --> ... of the "Radioimmunoassay Market by Type ...
(Date:11/25/2015)... 25, 2015 ... the "Global Brain Monitoring Devices Market ... --> ) has announced the ... Devices Market 2015-2019" report to their ... ( ) has announced the addition ...
(Date:11/25/2015)... 2015  Amgen (NASDAQ: AMGN ) today announced ... the United States (U.S.) Food ... candidate to Humira ® (adalimumab). Amgen believes this ... the FDA and represents Amgen,s first BLA submission using ... , M.D., executive vice president of Research and Development ...
Breaking Medicine Technology:
(Date:11/27/2015)... , ... November 27, 2015 , ... ... the toilets were," said an inventor from Hillside, N.J. "Many people catch diseases ... cover so that individuals will always be protected from germs." , He developed ...
(Date:11/27/2015)... ... November 27, 2015 , ... ProSidebar: Fashion is ... Pro X. With ProSidebar: Fasion, video editors can easily add an informative sidebar ... minimalist title opener. Utilize presets featuring self-animating drop zones, lines, bars, and text ...
(Date:11/27/2015)... ... November 27, 2015 , ... ... well-respected Microsoft Dynamics SL User Group (MSDSLUG). Recognized as Microsoft’s official group for ... of Microsoft Dynamics SL software users, partners, industry experts and representatives. Intellitec Solutions’ ...
(Date:11/27/2015)... ... 27, 2015 , ... Keeping in mind challenges faced by ... wellness consultation, has collaborated with a leading web-based marketplace for extra-curricular activities for ... parents and bring advice from parenting experts within their reach. As a part ...
(Date:11/27/2015)... ... November 27, 2015 , ... Dr. Thomas Dunlap and ... and Dr. Tucker Bierbaum with Emergency Medicine at St., Joseph Health System’s Santa ... and Sepsis conditions present in similar ways and require time-critical intervention to avoid large ...
Breaking Medicine News(10 mins):