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FDA recalls of medical devices including diagnostics, implants, and consumer health hardware.
Medical device recalls are the FDA's highest-volume stream. They cover implantable devices like pacemakers and joint replacements, hospital diagnostics and lab analyzers, surgical instruments, software-as-a-medical-device, and consumer-facing hardware like CPAP machines, blood-pressure cuffs, and glucose monitors. The volume comes from the wide range of products in scope and from the FDA's broad definition of 'corrective action' — software updates, IFU revisions, and labeling corrections all show up as recalls.
For Class I device recalls, the device's defect creates a reasonable risk of serious injury or death — these are the urgent ones. Class II covers issues that may cause temporary or medically reversible harm, often around accuracy or calibration. Class III is for products that don't comply with FDA rules but pose no real safety risk; in practice many software-update letters are Class III.
If you depend on a recalled device for ongoing care, don't disconnect or stop using it before talking to the prescribing clinician — interrupting therapy for a CPAP or a continuous glucose monitor can be more dangerous than the recall it's responding to. Almost every device recall offers a remedy that doesn't require you to surrender the device first.
Philips Respironics is recalling the Trilogy Evo ventilator (76,713 units) because it may suddenly stop ventilating when a false Battery Depleted or Loss of Power alarm triggers despite sufficient power available.
SonarMed Inc is recalling the AW-S025 NEO SONARMED SENSOR 2.5MM airway monitoring device due to a malfunction that causes it to fail detecting partial obstruction, potentially preventing clinicians from identifying compromised airways.
SonarMed Inc is recalling 690 units of the AW-S030 NEO SONARMED SENSOR because the sensor fails to detect partial airway obstruction. The devices were distributed across 20 US states.
Philips Respironics is recalling Aeris EVO ventilators due to a software defect that may cause false battery or power alarms while the device retains adequate power, risking sudden loss of ventilation in pediatric and adult patients. Approximately 775 units are affected.
Philips Respironics is recalling 789 Trilogy Evo O2 ventilators due to a software defect that can trigger a false power alarm despite sufficient power, potentially causing sudden loss of ventilation in pediatric and adult patients.
Philips is recalling 56,012 Trilogy EV300 ventilators due to a software defect that can trigger a false Battery Depleted or Loss of Power alarm despite adequate power, risking sudden loss of ventilation.
Philips is recalling the Trilogy Evo Universal Ventilator for a software defect that triggers false low-battery or power-loss alarms despite sufficient power, risking sudden ventilation loss.
A software anomaly in SonarMed's AW-M0001 airway monitor prevents detection of partial airway obstructions in 2.5mm and larger sensors. The device may fail to alert clinicians to blockages, affecting approximately 145 units across 19 states.
Masimo Rad-G pulse oximeters may unexpectedly power off and on, potentially losing monitoring capability. About 4978 units affected worldwide.
Philips is recalling 672 units of its SmartPath to dStream MRI system because the patient support table floor plate may be incorrectly installed, posing a patient safety risk.
Philips is recalling the MR 7700 Magnetic Resonance System due to potential incorrect installation of the patient support table floor plate. The recall affects 26 units distributed worldwide.
Cook Incorporated is recalling 55 Peel-Away Introducers due to packaging with low seal strength that may compromise device sterility.
Baxter Healthcare is recalling marketing brochures for surgical vessel occluders and related devices because the brochures contain information that does not match the official product instructions for use.
Philips North America is recalling GYROSCAN T10-NT MRI systems due to potential incorrect installation of the patient support table floor plate. Affected units should be verified for proper installation.
Philips is recalling 46 units of the Intera 1.5T Achieva Nova MRI system due to improper installation of the patient support table floor plate. The defect may compromise patient safety during use.
Conformis is recalling Identity Imprint PS Tibial Tray Size 4 implants due to a packaging error where Size 5 components were placed in Size 4 boxes with incorrect lot numbers.
Randox Laboratories is recalling its Microalbumin Calibrator Series due to a negative bias in its calibration. This could misclassify patient results and affect Quality Control procedures by up to 12%.
Philips is recalling one Achieva 3.0T for PET MRI system with a patient support table floor plate that may be incorrectly installed.
Philips is recalling 69 units of the Achieva 1.5T Initial MRI system due to potential issues with the patient support table floor plate installation, which may affect patient safety during imaging.
Philips is recalling 135 Ingenia 1.5T S MRI systems worldwide because the patient support table floor plate may be incorrectly installed, creating a potential safety risk to patients and staff.
Surgical Specialties is recalling POLYSIN (Polyglycolic Acid) surgical sutures due to incorrect needle curvature. This defect could affect proper suture placement during surgical procedures.
Philips Ingenia Ambition X MRI systems may have incorrectly installed patient support table floor plates. This affects 404 units distributed worldwide.
Philips is recalling certain Intera 1.5T MRI systems because the patient support table floor plate may be incorrectly installed, which could affect patient safety.
Philips GYROSCAN T5-NT MRI systems may have an incorrectly installed patient support floor plate. Affected units should be inspected to ensure proper installation.
Philips is recalling the Achieva 3.0TX PET-MRI system because the patient support table floor plate may be incorrectly installed.
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