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
Cordis US Corp is recalling the ANGIOGUARD RX/XP Emboli Capture Guidewire System (1,087 units worldwide) due to potential separation of the delivery system and capture sheath, which could lead to stroke.
Cordis US Corp's ANGIOGUARD RX/XP Emboli Capture Guidewire System is being recalled by the FDA (Class I) because the delivery system and capture sheath may separate during medical procedures, potentially requiring emergency intervention.
Covidien is recalling Shiley Adult Flexible Tracheostomy Tubes due to undersized connectors that create loose connections with 15mm respiratory circuit components. Unsecure connections could cause respiratory failure, difficulty breathing, treatment delays, or serious injury.
Fresenius Kabi is recalling the Ivenix Infusion System Large Volume Pump (Model LVP-0004) because fluid ingress can damage the device, causing loss of electrical function and preventing or halting infusion.
FreeStyle Libre Reader batteries may swell, overheat, or create fire hazard. Do not use if the device is damaged, cracked, swollen, excessively hot, won't hold charge, or fails Reader Test.
The Trilogy EV300 Portable Electric Ventilator may deliver insufficient oxygen during high-concentration therapy due to accuracy deviations. The device's internal oxygen sensor may also display incorrect readings, creating a risk of oxygen under-delivery to patients.
Philips Respironics is recalling the Trilogy Evo Universal Portable Electric Ventilator (Model DS2000X11B) because it may deliver oxygen below the prescribed level during high-concentration oxygen therapy, potentially depriving patients of adequate oxygen.
Abbott is recalling over 1.3 million FreeStyle Libre Readers nationwide due to lithium-ion battery swelling, overheating, and fire hazards. Users should stop use if devices show damage, swelling, or excessive heat.
FreeStyle Libre Reader batteries used in glucose monitoring systems may swell, overheat, or pose a fire hazard. Users should only charge with the included cable and discontinue use if devices show damage, excessive heat, or charging problems.
Philips DreamStation BiPAP and CPAP devices may experience communication failures with their cloud care management system, potentially preventing proper prescription settings from being downloaded to the device.
Philips Respironics ventilators may deliver oxygen below required tolerance during high-concentration therapy. The FiO2 sensor may display higher readings than actual delivery, risking insufficient oxygen to patients.
Avanos Medical recalls BALLARD ACCESS Closed Suction System units due to manifold cracking, which can cause respiratory circuit leaks and inadequate ventilation in neonatal and pediatric patients.
Avanos Medical is recalling 780 units of the BALLARD ACCESS Closed Suction System due to manifold cracking that can leak the respiratory circuit, potentially causing inadequate ventilation in neonatal and pediatric patients.
The Cardiosave Rescue intra-aortic balloon pump may suddenly stop working due to communication failure between internal circuit boards, interrupting patient therapy and threatening hemodynamic stability.
The Cardiosave Hybrid intra-aortic balloon pump (IABP) is being recalled because it may unexpectedly shut down due to communication loss between internal components. The shutdown could interrupt therapy in cardiac patients and compromise their hemodynamic stability.
Datascope Corp. is recalling Cardiosave Rescue Intra-Aortic Balloon Pumps due to a coiled cord cable connection failure that may cause unexpected device shutdown and loss of communication.
Datascope Corp. is recalling Cardiosave Hybrid IABP devices due to a connection failure that may cause unexpected shutdown during use. The failure prevents communication between the device's display head and base unit.
The FDA recalls Baxter's Life2000 Ventilator due to potential patient desaturation when connected to an oxygen concentrator. Affects 71 units nationwide.
Baxter Healthcare is recalling 8 Life2000 Hospital Ventilator systems due to potential patient desaturation events when the device is connected to an oxygen concentrator.
Baxter Healthcare is recalling 135 Life2000 ventilators nationwide due to potential patient desaturation when connected to an oxygen concentrator.
Baxter Healthcare is recalling 4,279 Life2000 Ventilator Systems due to potential patient desaturation when connected to oxygen concentrators.
Draeger Medical is recalling 893 units of NovaStar TS Standard elbow components due to magnets that could interfere with medical devices and metallic implants.
Draeger Medical recalls NovaStar TS Anti-Asphyxia Valves due to magnets that may interfere with implanted and non-implanted medical devices and metallic implants.
GE Nuclear Medicine 600/800 series imaging systems may have faulty detectors that could fall, causing serious injury. Mitigation measures may not be properly implemented on 34 units distributed worldwide.
GE Nuclear Medicine 600/800 series systems (748 units distributed worldwide) may have improperly implemented detector fall mitigations. If the mitigation fails, the detector can fall and cause life-threatening bodily injury.