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.
DePuy Orthopaedics is recalling a specific femoral revision implant because burrs may be present on the extraction hole threads.
Kroger Specialty Pharmacy is recalling Cayston 75 mg inhalation solution due to lack of processing controls. The product was distributed in five states.
ICU Medical is recalling 36 hemodynamic monitoring systems because the catheter thermal coil may continue operating while in Pause mode.
Zimmer Biomet is recalling 54 Gentle Threads Interference Screws because overexposure to ethylene oxide sterilization may compromise the sterile barrier, increasing infection risk.
Siemens Healthcare Diagnostics is recalling one lot of Dimension Lipase Flex Reagent Cartridges due to calibration failure causing positive bias in test results.
Straumann Manufacturing is recalling specific lots of Emdogain because a raw material shelf life change was made without data proving the product remains effective.
TP Orthodontics is recalling 7 Jasper Vektor Class II Correction Appliances because the devices may break in the patient's mouth, posing a risk of injury.
Siemens Healthcare Diagnostics is recalling specific lots of Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridges because the instructions for use do not list the biotin concentration that causes interference.
Inpeco S.A. is recalling 18 laboratory automation systems because a module may freeze without warning, potentially delaying patient test results.
Volkswagen Group of America is recalling 2018 Audi S5 Cabriolet vehicles because the front passenger seat-mounted air bag may have been folded incorrectly, increasing injury risk in a crash.
Datascope Corporation is recalling four custom tubing kits because a seal defect may allow air to enter the housing, potentially collapsing the balloon and reducing blood flow.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Cyclosporine because the instructions for use incorrectly state the biotin non-interference level.
Kroger Specialty Pharmacy is recalling one lot of Capecitabine 150 mg tablets because the product lacks required processing controls. The recall affects units dispensed in Mississippi, Louisiana, Arkansas, Illinois, and Florida.
Kroger Specialty Pharmacy is recalling Botox 100 Units Vials because of a lack of processing controls. The product was distributed in MS, LA, AR, IL, and FL.
Kroger Specialty Pharmacy is recalling one lot of Imatinib Mesylate 400 mg tablets because the product lacked required processing controls.
Vygon U.S.A. is recalling 16,520 Neonatal PICC Trays because potential friction holes may affect the product's sterility.
Kent Quality Foods is recalling approximately 308,430 pounds of hot dog and sausage products because they contain undeclared soy, a known allergen.
Cook Inc. is recalling 220 connecting tubes because the cap-adapter assembly may not be adequately tightened, potentially leading to fluid leakage or air aspiration.
Baxter Healthcare is recalling 444 Sigma Spectrum Infusion Pumps because technicians omitted required safety tests, potentially compromising air and occlusion detection.
Bard Brachytherapy is recalling Iodine-125 radioactive seeds because incorrect dosage levels were mixed up and sent to two hospitals in California and Georgia.
Bard Peripheral Vascular Inc is recalling 1551 units of the POWERPORT ClearVUE Slim catheter because the included Patient ID Card has incorrect port flushing instructions.
Keystone is recalling 2019 Cougar fifth-wheel trailers because the propane compartment may not be sealed properly, posing a risk of gas seepage into living quarters.
Kroger Specialty Pharmacy is recalling Lupron Depot 22.5 mg 3 month Kits due to a lack of processing controls. The recall affects lots dispensed in MS, LA, AR, IL, and FL between December 2017 and February 2018.
Vitalab Pharmacy is recalling specific lots of sterile injectable drugs because airflow patterns may not support aseptic production.
Baxter is recalling 444 Sigma Spectrum Infusion Pumps because technicians omitted specific safety tests. The missing tests for air and occlusion detection could lead to serious health consequences.