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.
Hamilton Medical is recalling 6 control board spare parts for ventilators due to degrading capacitors that may leak electrolyte and cause electrical short circuits, potentially interrupting ventilation.
Hamilton Medical is recalling 76 Hamilton-T1 ventilators because degrading capacitors on the control board can leak electrolyte, potentially causing interruption of ventilation.
OBC GROUP CORP is recalling NUT DIET MAX dietary supplement capsules due to substitution with toxic Yellow Oleander instead of the labeled ingredient Nuez de la India.
OBC GROUP CORP has recalled LA ORIGINAL NUT DIET MAX due to product mislabeling. The product contains Yellow Oleander instead of the labeled Nuez de la India.
Novartis is recalling SANDIMMUNE Oral Solution bottles nationwide because they were found to contain crystals. Patients should contact their pharmacy or prescriber about affected bottles.
Hamilton Medical recalls 1,216 Hamilton-T1 ventilators due to degrading capacitors on the control board that may leak electrolyte and interrupt ventilation. The recall affects units distributed nationwide in the US and Puerto Rico.
Hamilton Medical is recalling ventilator spare parts (ESM Shielding Set) due to potentially degrading capacitors on the control board. These capacitors may leak electrolyte and cause a short circuit, interrupting ventilation.
Shimano is recalling about 680,000 bonded 11-speed road cranksets because the crank parts can separate and break, posing a crash hazard. Six injuries including bone fractures have been reported.
Abbott Medical is recalling Proclaim Plus 5 Implantable Pulse Generators (Model 3670) due to reports that patients are unable to exit MRI mode on the devices.
Abbott Medical recalls Infinity 7 Implantable Pulse Generators due to reports that patients cannot exit MRI mode. The FDA has classified this as a Class I recall affecting devices distributed worldwide.
Texas Tamale Company is recalling Black Bean Tamales due to undeclared milk. The product poses a risk to consumers with milk allergies.
Abbott Medical is recalling Proclaim XR 7 Implantable Pulse Generators due to a malfunction that prevents patients from exiting MRI (Magnetic Resonance Imaging) mode, potentially disrupting normal device operation and therapy delivery.
Mallinckrodt Manufacturing is recalling approximately 13,600 One-Way Valves used with ventilators due to risk of valve sticking and oxygen flow reduction. The Class I recall affects worldwide distribution.
Zespri Organic Green Kiwi from New Zealand is being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed across 14 states.
Todorganic Inc. is recalling TODRGANIC Natural Products NUEZ DE LA INDIA (Lot 168, EXP 10/24) because the product contains Yellow Oleander instead of the labeled ingredient. Yellow Oleander is toxic if ingested.
WEFUN Capsules 825 mg are being recalled due to contamination with sildenafil, an undisclosed active pharmaceutical ingredient not approved for the product. Distribution was nationwide.
Abbott Medical recalled the Proclaim XR 5 Implantable Pulse Generator after patients reported being unable to exit MRI mode on their devices. Approximately 113,784 units were distributed worldwide.
Zespri Organic Green Kiwi from New Zealand has been recalled due to potential Listeria monocytogenes contamination. The recalled pallet was distributed across 14 U.S. states.
Abbott Medical recalled Proclaim Plus 7 Implantable Pulse Generators due to a defect preventing patients from exiting MRI mode. This operational failure could compromise device functionality during or after magnetic resonance imaging procedures.
Medline Industries is recalling HUDSON RCI Addipak 5mL sterile saline inhalation solution due to sterility failure. Approximately 18,000 units were distributed nationwide; the product was intended for scrap but was inadvertently shipped to customers.
Some Abbott Infinity 5 implantable pulse generator patients report being unable to exit MRI mode on their devices. This Class I recall affects 5,932 devices distributed globally.
Generac is recalling about 64,000 portable generators because the fuel tank can fail to vent properly, causing excess pressure and fuel expulsion that poses fire and burn hazards. Generac has received 27 incident reports, including three with severe burn injuries.
Marlex Pharmaceuticals recalls Digoxin Tablets nationwide due to a labeling error where bottles are mislabeled with incorrect dosages. Bottles labeled as 0.125mg contain 0.25mg and vice versa.
Subaru is recalling 2024 Impreza vehicles because the front driveshaft assembly may develop cracks and break, potentially causing loss of drive power or vehicle rollaway, increasing crash risk.
Volkswagen Group is recalling 2019-2022 Audi sedans, wagons, and allroad models. Liquid in the rear seat may penetrate and shut down the gateway control module, suddenly reducing engine power and increasing crash risk.