Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
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.
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
Beckman Coulter is recalling Enzymatic Creatinine Reagents because high levels of acetaminophen metabolites may interfere with test results, potentially delaying diagnosis.
Beckman Coulter is recalling Triglycerides Reagent because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.
Michele's Granola LLC is recalling Salted Maple Pecan Granola because the ingredient list on the label fails to disclose pecans.
Stryker is recalling 12 Connected OR Carts because the monitor may not attach correctly, posing a risk of the monitor falling and injuring users.
Turtle Top is recalling 2019 Odyssey vehicles because the seatbelt-unfastened warning light may not illuminate for five seconds after ignition, increasing crash injury risk.
FDA recalls Triamcinolone Acetonide/Bupivacaine Injectable Suspension due to lack of sterility assurance. The drug was distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.
Siemens Healthcare Diagnostics is recalling Atellica CH Reaction Ring Segments because defects may allow water contamination, leading to inaccurate test results.
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
Bard Peripheral Vascular Inc is recalling specific lots of Bard Biopsy EnCor Probes due to performance failures including leaks and suction issues.
Seca is recalling 254 baby scale carts because wheels can loosen and detach, causing the cart to tip over and potentially injure a baby.
DeRoyal is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden, microbiological flora, and particulate contamination.
CJ Haide (Ningbo) Biotech Co., Ltd is recalling Aminature L-Cysteine HCl Anhydrous due to the presence of foreign metal material.
Respiratory Therapeutics Group is recalling RespVent Closed Suction System T-Pieces because catheters may not be tightly connected to the thumb port, potentially reducing suction performance.
Beckman Coulter is recalling Total Bilirubin Reagents because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.
DeRoyal Industries is recalling sterile custom kits containing Cardinal Health gowns due to unknown levels of bioburden and particulate contamination.
DeRoyal Industries is recalling 2,100 sterile custom kits containing Cardinal Health gowns due to unknown bioburden and particulate contamination.
Roche Diagnostics is recalling 684 units of Elecsys CA 19-9 reagent because non-reproducible elevated results may affect clinical interpretation.
Vyaire Medical is recalling 116 bellavista 1000 ventilators because they may fail to sound high-priority alarms or respond to touch screen input.
Covidien is recalling Force TriVerse Electrosurgical Kits distributed in EMEA due to potential sterile packaging compromise, which may increase infection risk.
Axia Pharmaceutical is recalling Testosterone Cypionate Injection because the product lacks assurance of sterility. The recall covers specific lots distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.
Baxter Healthcare is recalling Revaclear 300 Capillary Dialyzers because of the potential presence of particular matter in the header caps of ten lots.
Invivo Corporation is recalling 75 SensaVue DVI adapters for MRI monitors because they have insufficient shielding. The units were distributed in the U.S. and several foreign countries.
Beckman Coulter is recalling Uric Acid Reagents because high levels of acetaminophen metabolites may cause negative interference, potentially delaying diagnosis and treatment.