Early Alert: Convenience Kit Needle Issue from Integra LifeSciences

GE HealthCare issues updated use instructions for certain Carestation 600 and 700 series Anesthesia Systems

In May 2025, Medtronic issued a voluntary recall notification to global customers related to specific Newport™ HT70 and HT70 Plus ventilators and certain related Newport™ service parts. The FDA recently designated this voluntary action by Medtronic as a Class I recall.
With this recall, Medtronic i

Southwind Foods, LLC of Carson, California is voluntarily recalling a limited quantity of Frozen Shrimp, due to possible radionuclide (Cesium-137) contamination. Cs-137 is a man-made radioisotope of cesium. Traces of Cs-137 are widespread and can be present in the environment at background levels, a

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 07/03/2025
Short Title (70 char) Wedgewood Connect, LLC. San Jose, CA. 483 issued 07/03/2025
FEI Number 3003434972
Firm Name Wedgewood Connect, LLC
Record Type 483
State CA
Establishment Type Outsourcing Facilit

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 07/18/2025
Short Title (70 char) Right Value Drug Stores, LLC. Irving, TX. 483 issued 07/18/2025
FEI Number 3010589333
Firm Name Right Value Drug Stores, LLC
Record Type 483
State TX
Establishment Type Outsourci

As defined by FDA, real-world data (RWD) are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources and real-world evidence (RWE) is the clinical evidence regarding a medical product’s use and potential benefits or risks derived fr