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Sign up to receive FDA Enforcement Reports1 Whereas not all recalls are announced in the media or on our Recalls press release2 page, all recalls montiored by FDA are included in FDA’s weekly Enforcement Report once they are classified according to the level of hazard involved. 

 Abbott Diabetes Care, Inc. FreeStyle and FreeStyle Flash Blood Glucose Meters including the FreeStyle Blood Glucose Meter built into the OmniPod Personal Diabetes Manager (PDM) Abbott Diabetes Care has identified that certain meters have the potential to produce erroneously low blood

Covidien, Pipeline Embolization Device and Alligator Retrieval Device  – Coating on Delivery Wire Could Delaminate and Detach – (Certain Catalog / Lot Numbers) A recall has been issued for the Covidien, Pipeline Embolization Device and Alligator Retrieval Device (certain c

More than 90 percent of the country’s hospitals have received an incentive payment for their adoption or use of an electronic health record system, and the EHR implementations are expected to continue: About half of hospitals with 200 or more beds plan on purchasing a new EHR sy

The American Society for Healthcare Engineering of the American Hospital Association.  The Centers for Medicare & Medicaid Services (CMS) is accepting public comments on its proposed rule to adopt more recent versions of NFPA 101: Life Safety Code® and NFPA 99: Health Care Facilit

GenStrip Blood Glucose Test Strips May Report False Results.   HeartWare, Inc., Heartware Ventricular Assist System.  Baxter Healthcare Corporation, Sigma Spectrum Infusion Pumps Shasta Technologies GenStrip Blood Glucose Test Strips May Report False Results Today the U.S. Food and Dr

  Technology National Alarm Safety Meeting Generates Debate on Data Published on May 2, 2014 As reported in an April 30 press release from AAMI, nearly 100 healthcare technology stakeholders met last April in Arlington, VA, to kick off “an unprecedented two-year initiative to improve