Recalls
Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.
Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.
The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.
Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.
Minimum severity
Approximately 620,000 COVID-19 rapid test devices were distributed in the U.S. without FDA Emergency Use Authorization or approval. Consumers should not use these unauthorized test kits.
Philips Respironics is recalling Wisp and Wisp Youth nasal masks because they lack warnings about magnetic components that could interfere with implanted medical devices or cause eye injuries from metallic splinters.
Philips Respironics is recalling 930,813 DreamWisp Nasal Masks worldwide due to missing warnings about magnetic components that could interfere with implantable medical devices or cause metallic splinters.
Fresenius Kabi is recalling the Ivenix Infusion System (IIS) LVP Software version 5.2.0 because the display screen may freeze and become unresponsive, stopping medication flow and requiring immediate clinician intervention.
Philips Respironics is recalling DreamWear Full Face CPAP masks due to missing warnings about magnetic components that may pose risks to patients with implantable devices or metallic eye splinters.
Philips Respironics is recalling the Therapy Mask 3100 NC/SP because the product lacks warnings about magnetic components that may affect patients with implantable devices or metallic splinters in the eyes.
Philips Respironics Amara View Full-Face Mask lacks critical safety warnings about magnetic components for patients with implantable medical devices. The Class I recall affects 5.6 million units worldwide.
FDA recalls TANDEM LIFE LivaNova LIFESPARC Controllers due to critical software failures that cause the device to freeze, crash, or stop displaying data. The controllers are used in cardiopulmonary bypass procedures.
Baxter Healthcare Corporation is recalling the CLEARLINK System Non-DEHP Solution Set nationwide due to increased customer reports of leaks in the in-line injection site device.
Philips Respironics recalls Philips BiPAP A30 respiratory devices due to motor assemblies with nonconforming plastic that off-gases volatile organic compounds (VOCs). Patients should contact the manufacturer immediately.
Philips Respironics is recalling OmniLab Advanced + ventilators due to motor assemblies manufactured with nonconforming plastic that releases volatile organic compounds (VOCs). The 8 affected units were distributed across the US and internationally.
Philips is recalling BiPAP A40 respiratory support devices because motor assemblies were manufactured with nonconforming plastic that off-gases volatile organic compounds (VOCs). Approximately 1,414 units have been distributed domestically and internationally.
Philips Respironics is recalling 85 units of the OmniLab Advanced+ ventilation device due to motor assemblies containing nonconforming plastic that off-gasses volatile organic compounds.
Philips Respironics is recalling certain Philips OmniLab Advanced+ noninvasive ventilation devices due to motor assemblies with nonconforming plastic that can off-gas volatile organic compounds (VOCs). This is an FDA Class I recall.
Philips Respironics recalls 295 BiPAP V30 Auto respiratory devices due to motor assemblies with nonconforming plastic. These assemblies off-gas volatile organic compounds (VOCs) during device operation.
Medtronic Xomed is recalling NIM EMG Endotracheal Tubes due to reports of airway obstruction during use. The recall affects 23,820 units distributed worldwide.
Medtronic Xomed is recalling 81,555 NIM Contact EMG endotracheal tubes worldwide due to reports of airway obstruction during use.
Medtronic Xomed recalls 1.1 million NIM EMG Endotracheal Tubes worldwide due to reports of airway obstruction. FDA classified this as Class I.
The FDA is recalling INTERA 3000 implantable hepatic infusion pumps due to a malfunction causing higher-than-expected medication flow rates. Patients should contact their healthcare provider.
Getinge Servo ventilators may fail to deliver ventilation and stop functioning, potentially causing oxygen deprivation and serious harm to critical care patients.
Hamilton's HAMILTON-C6 intensive care ventilator status indicator board may become loose, allowing water or disinfectants to enter the device and cause technical faults that could force the ventilator into unsafe modes where patients breathe unassisted room air.
Synapse Biomedical is recalling the NeuRx Diaphragm Pacing System External Pulse Generator due to a circuit board defect causing performance degradation, potentially leading to cardiac complications, breathing failure, or device shutdown.
HeartWare HVAD System Batteries are being recalled due to electrical faults that may prevent the battery from powering the device controller, accepting charges, or maintaining charge. Approximately 19,616 batteries distributed worldwide are affected.
Medtronic is recalling 1,657 Crome implantable cardioverter defibrillators due to potential reduced shock energy during high-voltage therapy. Affected devices may deliver only 79% of programmed energy.
Medtronic's Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. Patients with affected models should contact their physician.