Medical device types
A sampling of the types of medical devices on the U.S. market, from electrical stimulators to CPAP and BiPAP machines. Most of these are U.S. Class II devices that require a cleared premarket notification (510(k)) to enable them to be marketed in the United States. And most of them have had a product safety recall or correction.
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Medical Device Headlines
One Contaminated Alcohol Pad, Multiple Recalls
A Lesson in Medical Device Supply Chain Quality At first glance, Cardinal Health's recent recall of Webcol™ Alcohol Prep Pads appears straightforward. A commonly used healthcare product was found to be contaminated with Paenibacillus phoenicis, creating a potential...
Early Alert: Windstone Medical Recall for Convenience Kits
FDA Warns of Convenience Kits Containing Recalled Cardinal Health Alcohol Pads The FDA has issued an Early Alert regarding several medical convenience kits distributed by Windstone Medical Packaging, Inc. that contain alcohol prep pads previously recalled by Cardinal...
FDA Issues Warning Letter for Modifications to Infant Products
FDA Issues Warning Letter to Happiest Baby Over SNOO Smart Sleeper Modifications and Quality System Deficiencies The U.S. Food and Drug Administration has issued a Warning Letter to Happiest Baby, Inc., manufacturer of the SNOO Smart Sleeper, citing unapproved device...
FDA Expands Draeger Atlan Anesthesia Workstation Correction
More anesthesia machines added to correction for potential ventilation failure The U.S. Food and Drug Administration (FDA) has designated a recent expansion of Draeger, Inc.'s Atlan anesthesia workstation correction as a Class I recall, the agency's most serious...
Warning Letter to Zoll Medical for Major QMS Violations
Warning Letter to Zoll Medical for Major QMS Violations The U.S. Food and Drug Administration has issued a Warning Letter to ZOLL Medical Corporation citing significant Quality System Regulation (QSR) violations involving corrective and preventive action (CAPA),...
Abiomed Issues Correction for Automated Impella Controllers
Hardware Updates Required to Address Potential Loss of Hemodynamic Support Abiomed has issued a correction for certain Automated Impella Controllers (AICs) used with the Impella heart pump system after identifying hardware-related issues that could lead to controller...
FDA Clears First OTC Continuous Glucose Monitor for Children
Regulatory Snapshot Device: Stelo® Glucose Biosensor System (Dexcom, Inc.)Indication: Continuous glucose monitoring for individuals ages 2 years and older who do not use insulin, including children with diabetes managed through oral medications and individuals seeking...
FDA Early Alert for Baxter Pressure Breathing Device
FDA Issues Early Alert for Baxter Volara System Patient Circuits Following Therapy Leakage Concerns The U.S. Food and Drug Administration (FDA) has issued an Early Alert regarding a potentially high-risk issue affecting certain Baxter Volara System patient circuits...
FDA-Approved Vivistim: A New Pathway in Stroke Recovery
Vivistim implantable vagus nerve stimulator. Source: Vivistim.com.FDA-Approved Vagus Nerve Stimulation Device Opens a New Pathway in Stroke Recovery A company behind one of the world’s most closely watched neurorehabilitation technologies is preparing for a major new...
FDA Warning Letter Cites Systemic Aseptic Manufacturing Failures
Medline Warning Letter Signals Systemic Quality Failures in Cardiovascular Device Manufacturing The FDA has issued a Warning Letter to Medline Industries (NAMIC Division) following a December 2025 inspection, identifying significant Quality System Regulation (QSR)...