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.
Arrow International is recalling 127 units of the AutoCAT2WAVE Intra-Aortic Balloon Pump worldwide due to a potential issue with battery runtime.
Arrow AutoCAT2WAVE intra-aortic balloon pumps are recalled due to a potential issue with short battery run-times. Fifteen units distributed worldwide are affected.
Arrow AutoCAT2 intra-aortic balloon pumps may experience shorter battery run-times than specified, affecting device reliability in cardiac care. The FDA has issued a Class I recall for all affected units worldwide.
The Arrow AutoCAT2WAVE intra-aortic balloon pump is being recalled worldwide due to a potential issue with short battery run-times. Healthcare facilities should contact the manufacturer for guidance.
Arrow AC3 Optimus cardiac pumps may experience short battery run-times. The FDA has issued a Class I recall for all units worldwide.
Arrow AutoCAT 2 intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. Affected users should contact the manufacturer for guidance.
Exela Pharma Sciences is recalling 489,600 vials of sodium bicarbonate injection nationwide due to defective vials that break and release glass fragments when pressurized during preparation.
ARROW INTERNATIONAL is recalling Arrow MAC Two-Lumen Central Venous Access Kits due to potential inadequate connection between the top and bottom housings of included Micro Clave Clear Connectors.
Arrow AC3 Optimus Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. The FDA issued a Class I recall for these devices.
Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times. All lot and serial numbers are affected.
Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump due to a potential issue with short battery run-times. All lot and serial numbers worldwide are affected.
The Arrow AutoCAT2 intra-aortic balloon pump has been recalled due to potential short battery run-times. This Class I recall affects devices distributed worldwide.
Arrow International is recalling Arrow AutoCAT 2 intra-aortic balloon pumps worldwide due to a potential issue with battery run-times.
ARROW INTERNATIONAL is recalling 1,275 units of Arrowg+ard Blue Plus CVC kits due to inadequate connections in Micro Clave Clear Connectors. Units distributed in six states.
Arrow AutoCAT2 intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. The recall affects 12 units distributed worldwide.
Arrow AutoCAT2WAVE IABP devices have been recalled due to a potential issue with short battery run-times. The recall covers 112 units distributed worldwide.
Exela Pharma Sciences is recalling Sodium Bicarbonate Injection vials due to defective containers that may break and release glass fragments when pressurized during preparation. The recall affects 37,320 vials distributed nationwide.
Arrow AutoCAT2WAVE intra-aortic balloon pumps are being recalled due to a potential issue with short battery run-times. The Class I recall affects 48 units distributed worldwide.
Gyroor C3 e-bikes are recalled because the battery pack can ignite, creating fire and burn hazards. Gyroor has received reports of battery packs igniting and injuries requiring medical treatment, including burns and smoke inhalation.
Caire, Inc. is recalling five CAIRE Liberator 30 liquid oxygen system units due to weld defects on the inner bottle that could lead to device failure and loss of oxygen supply to dependent patients.
Caire, Inc. is recalling 10 CAIRE Liberator 45 liquid oxygen system units due to inconsistencies in weld penetration on the inner bottle discovered during an FDA audit.
Dewei DNA/RNA Preservation Kits (catalog DW-80005-1B) were distributed in the U.S. without FDA authorization or clearance. Approximately 1,348,000 units were distributed to California, Florida, Kentucky, and Michigan.
Remel Inc. recalled 8,073 units of Sensititre GN7F antibiotic susceptibility test plates after discovering they may report false results for certain bacteria, potentially leading to incorrect antibiotic treatment decisions.
Thermo Scientific Sensititre CMC7AFLF Gram Negative diagnostic tests may produce false susceptible results for certain bacteria, potentially leading to ineffective antibiotic treatment decisions. The FDA has classified this as a Class I recall.
GREEN DAY PRODUCE is recalling enoki mushrooms (UPC 16430-69080) due to Listeria monocytogenes contamination. Affected products were distributed to retailers and distributors in 12 states.