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
Draeger Medical is recalling approximately 35,950 Drager SafeStar 55 medical devices due to a manufacturing error that may cause occlusion of the device's filters, potentially preventing proper device function.
Medtronic is recalling HeartWare HVAD Pump Implant Kit units due to a welding defect in the center post cap that can lead to pump malfunction and affect blood flow.
GE Healthcare is recalling multiple ventilator models due to insufficient battery backup power. The affected units may shut down prematurely when not connected to AC power.
GE Healthcare is recalling backup batteries for ventilators used in critical care. The batteries may not provide sufficient backup power when disconnected from AC, potentially causing unexpected device shutdown.
Baxter Healthcare is recalling 259 in-line ventilator adaptors due to potential risk of reduced oxygenation or barotrauma when used with Volara systems in home care settings.
The FDA is recalling approximately 4,449 Sara Plus Active Floor Lift devices due to a fire hazard. The devices may emit smoke or ignite, posing a risk to users and staff.
Avanos Medical is modifying labeling for the Cortrak 2 Enteral Access System and discontinuing the Anonymous Account Mode feature. Users must confirm tube placement per institutional protocol.
Atrium Medical is recalling the iCast Covered Stent System because the balloon or catheter hub may separate from the delivery catheter during use, potentially causing blood clots, vessel blockages, or organ damage.
Abbott Vascular recalls 14,544 Dragonfly OpStar Imaging Catheters due to potential separation of the proximal marker. The affected devices were distributed throughout the US and internationally.
Atrium Medical is recalling the Advanta V12 Covered Stent System worldwide for potential separation of the balloon or catheter hub during withdrawal, which may cause procedural delays and serious complications including embolism and organ infarction.
Mesa Biotech is recalling approximately 6,162 units of the Accula SARS-CoV-2 Test due to an increased risk of false positive results, which could delay correct diagnosis and treatment.
Woodside Acquisitions Inc. recalled 34,240 Oral Rapid SARS-CoV-2 Antigen Test Kits distributed in Alabama and Georgia. The tests were distributed without FDA clearance or authorization for marketing.
The FDA is recalling 17,000 units of Joysbio SARS-CoV-2 Antigen Rapid Test Kits distributed in Alabama and Georgia. The tests were sold without FDA clearance or authorization for marketing in the United States.
SML Distribution is recalling 209,450 units of Skippack COVID-19 rapid test kits that were distributed without FDA authorization or clearance. The kits were distributed nationwide across Alabama, Florida, Georgia, Missouri, New York, Texas, and Wyoming.
Celltrion USA Inc. is recalling Celltrion DiaTrust COVID-19 Ag Rapid Test kits distributed to facilities without valid CLIA certification. The tests were distributed nationwide from December 2021 through February 2022.
The Puritan Bennett 980 Series Ventilator may fail to sound its audible alarm or display its visual alarm during critical alarm states, potentially delaying treatment response.
Intuitive Surgical recalled SureForm surgical staplers after tissue pushout events caused unexpected bleeding during procedures. The actual harm rate exceeded safety predictions.
Philips Respironics V680 Ventilators may stop operating due to an internal electrical circuit fault. Units were distributed worldwide and across the United States.
Philips Respironics V60 ventilators are recalled due to an internal electrical circuit defect that may cause the device to stop operating. Approximately 87,138 units worldwide are affected.
Medtronic is recalling 1,483 Harmony Delivery Catheter Systems due to potential capsule bond failure during pulmonary valve replacement procedures. The FDA has classified this as a Class I recall affecting devices distributed in the US and Canada.
Philips Respironics V60 Plus Ventilators are recalled for an internal electrical circuit defect that could cause the device to stop operating. Approximately 12,145 units were affected worldwide.
Sensory Medical Inc recalled 225 units of the Cub 2 Enclosed Bed Canopy System for potential misuse risk. The firm is updating product warnings and precautions for devices distributed before December 16, 2021.
Philips Respironics recalls 229,353 respiratory ventilators because polyester-polyurethane foam may degrade and release particles. Foam degradation could compromise ventilator function.
SD Biosensor's STANDARD Q COVID-19 Ag Home Test kits were illegally imported without FDA approval, clearance, or authorization. Approximately 400,000 units were distributed nationwide.
The Medtronic TurboHawk Plus Directional Atherectomy System (catalog THP-S) is being recalled due to design similarities to another device that experienced tip detachment and embolization. The recall affects 245 devices distributed nationwide.