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Recall of Sterile Compounded Products

An Arkansas medical compounding company has announced a nationwide recall of all lots of...

Company Notifies Hospitals of Ventricular Assist Device Issues

A California medical device manufacturer has issued a voluntary Urgent Medical Device Correction Letter...

Angiographic Catheters Recalled

Cook Medical of Bloomington, IN has announced the recall of nearly 100,000 of the...

FDA’s CDRH Seeking Customer Feedback

The U.S. federal agency responsible for the regulation and oversight of medical devices is...

Medical Device Cybersecurity Guidelines Released

The Food and Drug Administration has announced guidelines for cybersecurity for medical device manufacturers....
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Recalled Medical Product Lacked FDA 510(k) Approval

In conjunction with the U.S. Food and Drug Administration (FDA), ConvaTec, Inc. has initiated...

Voluntary Recall of Breast Pump AC/DC Power Adapters Expanded

Playtex Manufacturing, Inc. added a production lot to a March 2014 voluntary recall of...

TIA Commends New FDA Approach to Medical Device Data Systems

The Telecommunications Industry Association (TIA) submitted comments to the Food and Drug Administration (FDA)...

Medical CO2 Detectors Recalled

GE Healthcare, LLC, of Waukesha, WI has issued a recall of certain models of...

Infusion Pump Manufacturer Announces Corrective Action

Hospira, Inc. of Lake Forest, IL has issued an urgent correction notice in connection...
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