Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.
FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.
Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.
Draeger Medical is recalling approximately 16,841 Dräger Perseus A500 Anesthesia Workstations due to unexpected shutdown while operating on battery power. The devices have been distributed nationwide and internationally.
Philips Respironics is recalling 789 Trilogy Evo O2 ventilators due to a software defect that can trigger a false power alarm despite sufficient power, potentially causing sudden loss of ventilation in pediatric and adult patients.
HandNatural is recalling H&Natural Brazil Seed 30-piece supplements due to the presence of yellow oleander and its components in the product. Consumers should stop using the product immediately and dispose of it safely.
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.
HandNatural Brazil seed supplement recalled for containing yellow oleander, a toxic plant. Affected products sold online with expiration dates 05/24 and 03/24.
Amneal Pharmaceuticals is recalling Vancomycin Hydrochloride Oral Solution nationwide due to manufacturing overfilling causing superpotency with higher-than-labeled concentration. The FDA classified this as Class I.
Philips Respironics is recalling Aeris EVO ventilators due to a software defect that may cause false battery or power alarms while the device retains adequate power, risking sudden loss of ventilation in pediatric and adult patients. Approximately 775 units are affected.
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.
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.
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.
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.
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.
A software anomaly in SonarMed's AW-M0001 airway monitor prevents detection of partial airway obstructions in 2.5mm and larger sensors. The device may fail to alert clinicians to blockages, affecting approximately 145 units across 19 states.
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.
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 H&Natural Tejocote Root dietary supplement because the product contains yellow oleander and its components, which pose a health risk.
Elekta recalled disposable biopsy needles from batch 837838839 that may contain microscopic stainless steel debris inside. The sterility of the needles has not been affected, and this issue has been reported from only one site.
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.
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.
HandNatural is recalling H&Natural Brazil Seed supplements because the product contains yellow oleander, a toxic plant that poses serious health risks. Consumers should stop using the product immediately.
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 is recalling H&NATURAL BRAZIL SEED, a dietary supplement sold online, due to contamination with yellow oleander, a toxic plant component.
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 is recalling its tejocote root supplement because the product contains yellow oleander and its components. Consumers should not use this supplement.
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.