Severity 5 of 5
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Severity 5 (Critical) covers recalls where deaths or serious injuries have been reported, or where the agency itself classified the action as the highest severity (FDA Class I, NHTSA 'death/serious injury reported'). These are the recalls you should treat as urgent — stop using the product immediately and follow the agency's guidance. Common Severity-5 categories are pathogen-contaminated ready-to-eat foods (Listeria, E. coli O157, Salmonella), drug products with confirmed adverse-event reports, and vehicle defects with documented fatal crashes.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Fresh Express Inc is recalling Twisted Chopped Caesar salad in 9.4oz packages due to potential Listeria monocytogenes contamination. The product was distributed to retailers in 20 U.S. states and Canada.
Medtronic is recalling the HawkOne Directional Atherectomy System globally due to reports of tip damage that can detach and cause embolization. The device is used to remove arterial plaque in peripheral blood vessels.
Valisa MFG LLC is recalling kleantouch Hand Sanitizer 8 FL OZ pump bottles nationwide because the product contains methanol and was marketed without FDA approval. Consumers should stop using the product immediately.
Longwood Forest is recalling Angel Line bunk beds with angled ladders because the metal hook fastening the ladder can detach or move, creating gaps that pose serious entrapment and strangulation hazards. A 2-year-old child died in May 2018 when found unresponsive in a bunk bed ladder gap.
Compass Health Brands is recalling Carex Brand Adult Portable Bed Rails due to entrapment and asphyxiation hazards. Three deaths have been reported when users became trapped within the rails or between the rail and mattress.
Essential Medical Supply is recalling approximately 272,000 Endurance Hand Bed Rails because users can become entrapped within the rail or between the rail and mattress, posing a risk of asphyxiation. One death has been reported.
Royal Sovereign International is recalling about 33,570 portable air conditioners due to a faulty drain motor that can ignite the plastic enclosure, causing fires and burns. One death from smoke inhalation has been reported, along with 11 incidents of fires or smoking and over $1 million in property damage.
Covidien is recalling 278 Puritan Bennett 980 Series Ventilators worldwide due to incorrect capacitor assembly that may cause devices to become inoperable during patient use.
Drive DeVilbiss Healthcare is recalling four models of adult portable bed rails that can trap users between the rail and mattress, causing asphyxiation. Two deaths have been reported.
ROSA One 3.1 surgical guidance system recalled due to a software anomaly causing inaccurate electrode placement during brain and spine surgery. Manufacturer received 3 complaints related to the issue.
Beiersdorf Inc. is recalling Coppertone Pure & Simple 50 Sunscreen Spray due to the presence of benzene, a chemical contaminant. The recall affects 38,328 cans distributed nationwide.
Walmart is recalling Better Homes and Gardens Essential Oil Infused Aromatherapy Room Spray with Gemstones due to contamination with Burkholderia pseudomallei bacteria. CDC testing identified the hazard and is investigating a cluster of four melioidosis cases, including two deaths.
Atrium Medical Corporation is recalling 92,430 units of its Pneumostat Chest Drain Valve after a preterm infant died during treatment with the device. The company is revising product labeling and warnings.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. The FDA recommends healthcare providers stop using these products immediately.
The Boppy Company is recalling approximately 3.3 million Boppy newborn loungers due to suffocation risk. Eight infant deaths have been reported associated with the product.
Micro Therapeutics recalls Pipeline Flex Embolization Devices for potential push wire fractures in the delivery system during use. Device fractures in the Hypotube may result in malfunction during vascular procedures.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. are being recalled due to potential bacterial contamination. The FDA issued a Class I recall on August 18, 2021, advising health care providers to stop using all affected products.
Cardinal Health recalls 267 million Monoject 0.9% Sodium Chloride Flush Syringes due to a plunger defect that may reintroduce air into the syringe, posing a risk of air embolism during IV administration.
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 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 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.
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 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 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 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.