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.
RaySearch Laboratories is recalling RayStation 9B software due to a dose calculation error that could underestimate radiation therapy doses.
Ventana Medical Systems is recalling 461 HE 600 instruments due to a cleaning solution leak that can cause electrical shorts and burned components.
La Sonorense, Inc. is recalling flour burrito tortillas sold in Arizona because the packaging did not properly list wheat as an allergen.
Smith & Nephew is recalling 1,450 R3 Zero Hole HA Coated Hemispherical Stiktite Coated Shells because a manufacturing error resulted in out-of-specification devices.
BioFire Diagnostics is recalling FilmArray BCID Panels due to a risk of false positive Proteus results when used with specific blood culture media, which may lead to improper antibiotic treatment.
Elekta Limited is recalling specific Unity software versions due to a potential mismatch between contour data and motion monitoring images.
Acuity Surgical Devices is recalling A Link Z Intervertebral Body Fusion Devices due to a manufacturing issue that may prevent vertebral body bone screws from seating properly.
Hardy Diagnostics is recalling HardyCHROM MRSA kits because they may produce false positive results for methicillin-susceptible Staphylococcus aureus.
ConAgra Foods is recalling Healthy Choice Pesto and Egg bowls because the farro ingredient may contain small stones.
Adams Extract & Spice LLC is recalling 1,389 units of Adams Reserve Sweet & Spicy Seafood Sauce due to undeclared soy lecithin. The product was distributed in Texas.
Pfizer is recalling specific lots of Unasyn (ampicillin sodium and sulbactam sodium) for injection because particulate matter was identified after reconstitution.
Siemens Healthcare Diagnostics is recalling Dimension Enzymatic Creatinine reagents because acetaminophen metabolites may interfere with test results.
Canon Medical System is recalling 46 Infinix-8000V systems because loose bolts may cause the catheterization table to tilt.
Siemens Healthcare Diagnostics is recalling Dimension Vista Enzymatic Creatinine test kits because acetaminophen metabolites may interfere with results.
Genicon, Inc. is recalling Natura Model 210-005-152 trocar handles because the plastic optical tip may detach from the metal shaft.
RaySearch Laboratories is recalling RayStation software versions 4.0 to 5.0 Service Pack 2 due to a dose calculation error that may underestimate radiation dose.
Siemens is recalling 15 Artis X-ray systems in the US because a power distributor defect may cause electrical contact interruptions, leading to procedure termination.
Canon Medical System is recalling 15 Infinix-8000F digital radiography systems because loose bolts may cause the catheterization table to tilt.
Intuitive Surgical is recalling 1,757 stainless steel reprocessing trays because holes in the sterilization wrap could compromise sterility and increase infection risk.
Biomet is recalling 38 Comprehensive VRS Inserter shoulder prosthesis devices because the central screw drill may seize, potentially extending surgery time.
Genicon, Inc. is recalling GENILook Model 200-105-251 cannulas because the plastic optical tip may detach from the metal shaft.
RaySearch Laboratories is recalling RayStation 8A software due to a defect in dose calculation algorithms that may underestimate radiation dose.
Genicon, Inc. is recalling GENILook Model 200-005-251 cannulas because the plastic optical tip may detach from the metal shaft.
Forest River, Coachmen, and Dynamax recreational vehicles have an Operator's Manual that incorrectly describes the automatic parking function, potentially causing drivers to rely on it incorrectly and risking vehicle rollaway or movement.
Lippert Components is recalling 3000 Series Frameless windows for recreational vehicles because the adhesive bond may fail, allowing glass to detach and become a projectile.