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
Philips Respironics has recalled Trilogy Evo Universal respiratory devices (model DS2000X11B) for software defects that increase pressure, particularly in pediatric and infant applications.
Ortho8, Inc. is recalling the Evexia Luxe DVT Prevention Device because it was marketed without required FDA clearance. The device is intended to prevent deep vein thrombosis.
Tornier recalls Aequalis Pyrocarbon shoulder implants (6,631 units) due to potential patient exposure to graphite substrate material. The units were distributed across multiple U.S. states.
A software defect in Philips CT imaging systems causes incorrect contrast volume calculations when patient weight units are set to pounds, resulting in increased contrast dosing recommendations. Three units with specific serial numbers are affected.
Delta Med SpA is recalling NEO DELTA Self Safe 1 IV catheters due to possible missing sterility. The recall affects 5,000 units distributed in Florida and Minnesota.
Philips Brilliance iCT CT systems with SynchRight P3T software may recommend incorrect contrast volume when patient weight is entered in pounds, potentially affecting patient safety.
Teleflex recalls RUSCH endotracheal tubes because the cuff can be inflated while the pilot balloon remains flat, preventing proper monitoring of cuff pressure.
Delta Med is recalling NEO DELTA SELFSAFE PUR T IV catheters due to possible sterilization failures. The recall affects 14,000 units distributed in Florida and Minnesota.
Ostial Corporation is recalling the FLASH Ostial System dual balloon angioplasty catheter due to a manufacturing issue that may prevent proper balloon deflation, potentially causing access site complications.
Philips Respironics recalls Trilogy Evo ventilators due to software issues that may increase pressure delivery to patients. The defect affects multiple product variants worldwide.
Teleflex Medical Europe Ltd. is recalling RUSCH Slick Set Cuffed Endotracheal Tubes because the cuff can inflate while the pilot balloon remains flat, potentially affecting airway pressure monitoring.
Medtronic is recalling 163 HeartWare HVAD Pump Implant Kits distributed worldwide due to higher rates of neurological adverse events, mortality, and pump malfunction compared to other cardiac assist devices.
Medtronic is withdrawing 4,078 HeartWare HVAD implants worldwide due to higher frequency of neurological adverse events, mortality, and potential pump restart failures compared to other available devices.
Heartware is recalling HVAD Pump Accessories due to clinical data showing higher rates of neurological adverse events and mortality compared to other left ventricular assist devices, and reports of pump malfunctions.
Medtronic is recalling the HeartWare HVAD Pump Implant Kit due to higher rates of neurological adverse events and mortality compared to other heart pump devices. The pump may also delay or fail to restart.
Medtronic recalled the HeartWare HVAD Implant Kit due to higher rates of neurological adverse events and mortality compared to other left ventricular assist devices. The pump may also fail to restart.
Medtronic is recalling the HeartWare HVAD Driveline Extension Cable (443 units) due to higher frequency of neurological adverse events and mortality in clinical comparisons with other heart assist devices. The pump may experience restart delays or failures.
Medtronic recalled the Heartware HVAD Outflow Graft worldwide due to higher rates of neurological events and mortality compared to other left ventricular assist devices, plus pump restart failures.
Medtronic is recalling the HeartWare HVAD heart pump implant due to higher rates of neurological adverse events and mortality compared to other devices. The internal pump may also delay or fail to restart.
Medtronic is stopping the HVAD System due to observational data showing higher mortality rates and neurological adverse events compared to other cardiac assist devices. The internal pump may also delay or fail to restart.
Baxter is recalling Dose IQ Safety Software for Spectrum IQ Infusion Pumps due to a software defect that creates a mismatch between displayed drug names and the device's drug library. This could lead to incorrect medication administration.
Medtronic is recalling the HeartWare HVAD left ventricular assist pump after observational data showed higher rates of neurological adverse events and mortality compared to alternative devices, plus reports of pump restart failure.
Baxter Healthcare Corporation is recalling the Spectrum IQ Infusion System due to system errors causing pump connectivity failures following certain network configuration changes.
BioMedical Equipment Service Co (BMES) recalls bezel repair parts for Alaris Infusion Pump Module Model 8100. Non-original parts may crack or separate, causing free flow, over-infusion, under-infusion, or interruption of infusion.
Biomet is recalling Arcos Modular Revision Hip System components that may develop fretting corrosion in the inner taper, risking device failure and the need for revision surgery. Affected patients should contact their healthcare provider.