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.
Samurai-X Honey 6800, manufactured by Pyramids Wholesale Inc., is recalled for containing undeclared sildenafil and/or tadalafil. The product was distributed nationwide and marketed without FDA drug approval.
Pyramids Wholesale Inc. is recalling all lots of GoHARD 25000 because it contains undeclared sildenafil and tadalafil. The product was marketed without FDA approval for these prescription-strength drugs.
Route 92 Medical recalls its Full Length 070 Reperfusion System due to potential distal tip separation at the proximal marker band, which could affect device delivery during interventional procedures.
Pyramids Wholesale Inc. is recalling libigrow RED DRAGON+ capsules nationwide because they contain undeclared sildenafil and tadalafil, prescription medications not approved by the FDA for this product.
The GOAT Sublingual Strip male enhancement product, distributed nationwide, was recalled for containing undeclared sildenafil and tadalafil. The product was marketed without FDA approval.
SonarMed Inc is recalling the AW-S025 NEO SONARMED SENSOR 2.5MM airway monitoring device due to a malfunction that causes it to fail detecting partial obstruction, potentially preventing clinicians from identifying compromised airways.
HandNatural's H&Natural Brazil Seed dietary supplement is being recalled due to the presence of yellow oleander, a toxic plant component. Distribution was exclusively through internet sales.
Tropicale Foods is recalling Helados Mexico Premium Ice Cream Minis due to potential Salmonella contamination. The recall affects 5,224 retail units distributed across six U.S. states.
HandNatural Brazil seeds (5g) have been recalled for contamination with yellow oleander, a highly toxic substance. FDA classified this as a Class I recall due to serious health hazards.
H&NATURAL Brazil Seed supplement is recalled due to the presence of yellow oleander, a toxic plant, in the product. No illnesses have been reported.
Philips is recalling 56,012 Trilogy EV300 ventilators due to a software defect that can trigger a false Battery Depleted or Loss of Power alarm despite adequate power, risking sudden loss of ventilation.
SonarMed Inc is recalling the AW-S035 NEO airway monitoring sensor due to failure to detect partial obstructions. The defect may prevent the device from alerting clinicians to airway obstruction.
H&Natural is recalling its tejocote root supplement because the product contains yellow oleander and its components. Consumers should not use this supplement.
Philips Respironics is recalling the Trilogy Evo ventilator (76,713 units) because it may suddenly stop ventilating when a false Battery Depleted or Loss of Power alarm triggers despite sufficient power available.
Philips Respironics is recalling the LifeVentEVO2 ventilator due to a software malfunction that can trigger a false Battery Depleted or Loss of Power alarm when power is sufficient, potentially causing sudden loss of ventilation.
HandNatural is recalling its Brazil seed dietary supplement because the product contains yellow oleander, a toxic plant substance. This FDA Class I recall poses serious health concerns.
Philips Respironics recalls 1,233 Garbin EVO ventilators. A software defect in the battery and power alarm system may cause sudden loss of ventilation despite adequate power supply.
SonarMed Inc is recalling 690 units of the AW-S030 NEO SONARMED SENSOR because the sensor fails to detect partial airway obstruction. The devices were distributed across 20 US states.
HandNatural is recalling H&NATURAL BRAZIL SEED, a dietary supplement sold online, due to contamination with yellow oleander, a toxic plant component.
Outset Medical is recalling Tablo Hemodialysis Systems because their silicone tubing may contain unremoved polychlorinated biphenyl acids (PCBAs), which could cause skin conditions, liver damage, reproductive harm, or cancer.
HandNatural Brazil seed supplement recalled for containing yellow oleander, a toxic plant. Affected products sold online with expiration dates 05/24 and 03/24.
Philips is recalling the Trilogy Evo Universal Ventilator for a software defect that triggers false low-battery or power-loss alarms despite sufficient power, risking sudden ventilation loss.
H&Natural Brazil Seed is a botanical supplement sold online that is being recalled because the product contains yellow oleander and its components. The manufacturer is HandNatural.
AvKARE recalls Atovaquone Oral Suspension due to potential Bacillus cereus contamination of a non-sterile product. The recalled lot (AW0221A, Exp. 08/30/2025) was distributed nationwide; 153 cartons affected.
H&NATURAL Brazil Seed supplement containing yellow oleander has been recalled by the FDA as a Class I health hazard. The product was distributed exclusively through internet sales.