Search Results for FDA Recalls

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CDRH Speeds Release of Device Recall Information By Zachary Brennan - Published 03 January 2017

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday began posting medical device recall information in a searchable database much earlier than the agency ever has before.

Categories: News, US, CDRH, Compliance, Crisis management, Government affairs, Medical Devices, Postmarket surveillance

Tags: device recalls, FDA recalls, recall coordinators

Bacterial Infections Push FDA to Recall Certain Endoscope Washers By Zachary Brennan - Published 13 November 2015

The US Food and Drug Administration (FDA) on Friday again ordered a recall of all Custom Ultrasonics’ Endoscope Washer/Disinfector models, also known as Automated Endoscope Reprocessors (AERs), to mitigate the risk of patient infection.

Categories: News, US, FDA, Compliance, Crisis management, Medical Devices, Product withdrawl and retirement, Quality, Regulatory intelligence

Tags: endoscope, bacterial infection, duodenoscope, FDA recalls

Number of Drug Recalls Surges at FDA, Led by Mid-Level Concerns By Alexander Gaffney, RAC - Published 11 August 2014

Recalls of pharmaceutical products have surged in recent years, and 2014 is already shaping up to be the biggest year for serious drug recalls in the last decade, according to data made publicly available by the US Food and Drug Administration (FDA) late last month.

Categories: News, US, CDER, Drugs, Postmarket surveillance, Product withdrawl and retirement

Tags: Recall, Drug Recalls, FDA Recalls, Drug Recalls Increasing, Class I Recall, Class II Recall, Class II Recall