Video News & Updates
Stay informed with the latest video news from the health and medical device industry. Watch FDA alerts, industry updates, and breaking news in an engaging video format.
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FDA Recall of Insulet Omnipod 5 Pods Raises Safety Concerns Over Connected Insulin Delivery Devices
A recall posted by the U.S. Food and Drug Administration (FDA), 2026 window has brought renewed scrutiny to connected drug delivery systems. The action involves specific Omnipod 5 insulin pump pods manufactured by Insulet Corporation, a widely used w...
CMS and FDA Launch RAPID Pathway to Accelerate Medicare Coverage for Breakthrough Medical Devices
The Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA) announced a new initiative on April 23, 2026, called the Regulatory Alignment for Predictable and Immediate Device Coverage Pathway, or RAPID. The prog...
FDA’s QMSR Inspection Update Signals New Compliance Standards for U.S. Surgical Device Suppliers
A stronger non-recall story from the April 14–20 window is the FDA’s April 14, 2026 posting of materials from its town hall on Quality Management System Regulation (QMSR) medical device risk-based inspections. The town hall itself was held on April 1...
FDA Class I Recall: Medline Angiographic Syringes Raise Safety and Supply Chain Concerns in U.S. Procedure Rooms
A Class I recall involving Medline’s Namic Angiographic Rotating Adaptor Control Syringes is drawing attention across the U.S. surgical and interventional supply market because it affects a product used in contrast-delivery workflows where connection...
FDA Class I Recall: Abiomed Impella Purge Cassettes Removed Over Risk of Pump Failure and Patient Harm
The U.S. Food and Drug Administration updated this safety communication on April 3, 2026 to state that Abiomed’s removal of certain Impella Purge Cassettes and Impella RP Pump Sets has been classified as a Class I recall, the FDA’s most serious recal...
Medtronic Wins FDA Clearance to Expand Stealth AXiS Into Cranial and ENT Surgery
MINNEAPOLIS, March 30, 2026 — Medtronic has widened its push in surgical robotics and navigation after winning U.S. Food and Drug Administration clearances that allow its Stealth AXiS platform to be used in cranial and ear, nose and throat (ENT) proc...
FDA Alert: Intuitive Surgical Stapler Reload Recall Disrupts Robotic Surgery Workflows and OR Supply Chains
The FDA’s March 18, 2026 early alert involving Intuitive Surgical’s 8 mm SureForm 30 gray reloads for curved-tip staplers used with compatible da Vinci Surgical Systems. The FDA said the problem involves reports of incomplete staple lines on blood ve...
FDA Launches AEMS Adverse Event Look-Up Tool to Modernize Drug Safety Monitoring
The U.S. Food and Drug Administration on March 11, 2026 launched a new adverse event look-up tool tied to a newly introduced platform described in early coverage as the FDA Adverse Event Monitoring System (AEMS), marking a significant modernization o...
Philips SmartHeart Wins FDA Clearance to Simplify Cardiac MRI Planning with AI
A new artificial intelligence-based cardiac imaging tool from Philips has received U.S. regulatory clearance, adding momentum to the broader shift toward AI-assisted workflows in radiology and cardiology. On March 6, 2026, Philips announced that the ...
FDA Class I Recall: Olympus High-Flow Laparoscopic Insufflation Units Pulled Over Overpressure Risk
The U.S. surgical community is responding to a Class I medical device recall involving certain high-flow laparoscopic insufflation units manufactured by Olympus Corporation. The recall, published by the U.S. Food and Drug Administration, affects spec...
Medline Sterile Saline Wound Wash Recall: Class II Sterility Concern Triggers OR and ASC Irrigation Stock Sweep
A product many perioperative teams treat as a low-risk staple—sterile saline wound wash/irrigation spray—just became a high-priority inventory check. The FDA’s recall database shows a Class II recall for Medline Sterile Saline Wound Wash, Cleansing &...
FDA GRAS Rule Under Scrutiny as RFK Jr. Targets Ultra-Processed Food Additive Oversight
A new federal health policy debate is intensifying after Robert F. Kennedy Jr. signaled plans to scrutinize the FDA’s long-standing “Generally Recognized as Safe” (GRAS) rule — a regulatory framework that allows food manufacturers to self-certify cer...
FDA Issues New Wave of High-Risk Medical Device Recalls — What U.S. OR Supply Chains Must Do Now
February 2026 — United States — The U.S. Food and Drug Administration (FDA) has recently posted a series of high-risk medical–device recalls and early alerts across multiple product categories, including neurovascular implants, glucose sensors, anest...