Severity 4 of 5
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.
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.
Ceither Adult Portable Bed Rails sold on Amazon violate federal regulations and pose a serious risk of entrapment and asphyxiation. Users can become trapped within the bed rail or between the rail and mattress.
Smiths Medical ASD Inc. is recalling 10,240 Pneupac paraPAC plus 310 ventilator kits due to risk of unintended tidal volume knob movement, affecting all serial numbers worldwide.
Smiths Medical is recalling BLUperc and BLUselect tracheostomy tube kits worldwide due to a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line, potentially compromising airway management.
B Braun is recalling the Infusomat Space Infusion Pump due to a sensor malfunction that can trigger false alarms, risking improper medication delivery.
Smiths Medical is recalling select BLUSelect tracheostomy tubes due to a manufacturing defect that could cause the pilot balloon to disconnect from the inflation line. No injuries have been reported.
Smiths Medical is recalling approximately 12,234 BLUselect, BLUgriggs, and BLUperc tracheotomy tube kits due to a manufacturing defect that may cause the pilot balloon to disconnect from the inflation line.
Olympus Corporation recalled 2,525 electrosurgical knives (KD-645L) nationwide after reports of serious injury from knives breaking off during use. Users must follow Instructions for Use regarding proper electrosurgical unit compatibility and output settings.
Olympus Corporation recalls 4,507 Triangle Tip Electrosurgical Knives (Model KD-640L) due to device fragmentation during use. The issue is linked to reports of serious injury and improper adherence to usage instructions.
The accelerator pedal in 2022 Rivian R1S and R1T vehicles may fail to detect pedal release, preventing auto-hold and park functions from activating and increasing crash risk.
Jaguar Land Rover is recalling certain 2024 Land Rover Range Rover and Range Rover Sport vehicles because body panels may not be bonded properly, reducing structural strength and increasing crash injury risk.
Petzl America is recalling three climbing harness models because they can be worn backwards, allowing the rope or carabiner to attach to a non-weight-bearing strap instead of the proper attachment point. This can cause users to fall from height and suffer serious injury or death.
Breas Medical is recalling the Vivo 45 LS ventilator due to potential elevated formaldehyde emissions into the patient breathing airpath under specific conditions.
Butternut squash cubes sold in Kentucky, Michigan, Ohio, and West Virginia are recalled due to potential Listeria monocytogenes contamination. Affected products have sell-by dates between July 9 and July 26, 2024.
JFE Franchising is recalling guacamole products due to Listeria monocytogenes contamination. Affected items were distributed in Kentucky, Michigan, Ohio, and West Virginia with sell-by dates from July 9 to July 26, 2024.
JFE FRANCHISING INC is recalling diced pepper and fajita mix products sold in Kentucky, Michigan, Ohio, and West Virginia due to potential Listeria monocytogenes contamination. Consumers should discard the products or return them to the store.
Fresenius Kabi is recalling LVP Primary Administration Sets due to a defect that may cause uncontrolled medication flow and potential overdose. The recall affects 4,500 pieces distributed in Colorado, Idaho, New Jersey, and Utah.
JFE Franchising Inc recalls 5oz packages of chopped cilantro with white onion due to potential Listeria monocytogenes contamination. Affected products were distributed in Kentucky, Michigan, Ohio, and West Virginia.
Baxter Healthcare Corporation is recalling 44,208 containers of Heparin Sodium in Sodium Chloride Injection nationwide after endotoxin testing revealed out-of-limit results. The contamination poses a risk of serious adverse reactions in patients receiving the intravenous medication.
Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for Trilogy Evo EV300 ventilators to resolve previously identified safety issues. Approximately 90,910 US units and 56,273 international units are affected.
Unilever North America is recalling Popsicle Jolly Rancher Frozen Confection Pops nationwide due to undeclared milk, which poses a risk to consumers with milk allergies.
Terrafina Golden Raisins (10oz) are being recalled due to undeclared sulfites. This FDA Class I recall affects products distributed to retailers in New York.
JFE Franchising is recalling medium and mild salsa products sold in Kentucky, Michigan, Ohio, and West Virginia due to potential Listeria monocytogenes contamination.
Philips Respironics is issuing a mandatory software update (Version 1.05.10.00) for Trilogy Evo ventilators worldwide to resolve identified safety issues. Users must apply the update and review the updated User Manual.
Chrysler is recalling 2024-2025 Dodge Hornet and Alfa Romeo Tonale vehicles because the brake pedal may collapse, causing loss of brake function and increasing crash risk. Dealers will reinforce the brake pedal arm at no cost.
Certain 2022-2024 Harley-Davidson FXLRST and 2022 FXRST motorcycles have brake lines that may contact the fuel tank and become damaged, risking loss of front brake function.