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FDA issues most serious recall for certain glucose monitor sensors

The Food and Drug Administration has identified a
Medical Device Safety

FDA issues alert on heart pump issue 

The Food and Drug Administration Feb. 3 released an early alert on a heart pump issue from certain Abiomed products.
Medical Device Safety

Olympus expands recall of endoscope needles

Olympus has expanded a voluntary recall of its ViziShot 2 FLEX Needles due to complaints of device components ejecting or attaching during procedures, the Food and Drug Administration announced Jan. 16. The company said it received reports of one patient death and one patient injury and advised users to cease use of the product immediately and quarantine all devices. Customers were instructed to return the devices to Olympus. The FDA announced a Class I recall of certain lots of the product in September. 
Recall Management, Supply chain management

UDI Forum 2025: Powered by the AHRMM LUC

Discover how UDI will improve patient care, ensure traceability, streamline workflows and unlock actionable data that drives innovation and prepares your organization for future challenges and opportunities.
UDI and Data Standards, Unique Device Identifier (UDI), Medical Device Technology, Logistics, Learning UDI Community, Medical Device Technology, Data & Insights

AHRMM Supply Chain Fundamentals

The Supply Chain Fundamentals eLearning series provides foundational skills for supply chain professionals. Participants will learn how to develop and apply tools, approaches, and techniques used in the design and operation of health care systems and the integrated supply chain.
Certified Materials & Resource Professional (CMRP), Unique Device Identifier (UDI), Career/Professional Development, FAHRMM

Supply Chain Fundamentals 2: The What and Why of UDI

This course is an introduction to UDI (Unique Device Identifier) and the principal benefits of this system for health care delivery.
Certified Materials & Resource Professional (CMRP), Unique Device Identifier (UDI)

FDA identifies, issues Class 1 recalls

The Food and Drug Administration has identified a recall by Cook Medical of Zenith Alpha 2 Thoracic Endovascular Graft proximal components after Cook Medical found that scrapings of polytetrafluoroethylene coating may be released inside the stent graft during use. Impacted components include all length ZTA2-P/PT devices with diameters between 40 mm and 46 mm.
Products, Medical Device Safety

Permanent recall issued for Baxter ventilation system

The Food and Drug Administration has identified a
Recall Management, COVID-19: CDC, FDA and CMS Guidance

FDA issues most serious recall for certain speed control dials used for wheelchairs

The Food and Drug Administration has identified a Class I recall of Max Mobility/Permobil SpeedControl Dials used with the SmartDrive MX2+ Power Assist Device for wheelchairs after identifying a design issue that can lead to unexpected behavior of the SmartDrive motor.
Recall Management
Legacy

AHRMM's Senior Director, Mike Schiller, Makes the Case for UDI Adoption

Supply Chain Strategies & Solutions Article
In an effort to better protect patients during product recalls, and to improve care at a population health level, hospitals must begin to accurately capture medical device data through UDI ad
Unique Device Identifier (UDI), Career/Professional Development