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.
QuVa Pharma is recalling 648 bags of oxyTOCIN 30 Units/500 mL because the product did not contain the active drug.
Genicon, Inc. is recalling Natura Model 210-005-051 cannulas because the plastic optical tip may detach from the metal shaft.
Canon Medical System is recalling 24 Infinix-8000C digital radiography systems because loose bolts may cause the catheterization table to tilt.
La Bodega Meat LLC is recalling approximately 83,038 pounds of raw beef products that were distributed without the benefit of import re-inspection.
Medtronic is recalling 177 Mazor X Surgical System Positioner Type II units because they may unexpectedly detach from the operating table, posing a risk of blunt injury to patients.
RaySearch Laboratories is recalling RayStation 8B Service Pack 2 software due to a defect in dose calculation algorithms that could underestimate radiation dose.
RaySearch Laboratories is recalling RayStation 5 Service Pack 3 software due to a dose calculation error that may underestimate radiation dose.
Endologix is recalling Ovation iX Abdominal Stent Graft Systems because a material weakness may cause polymer leaks during implantation, potentially leading to clinical events.
Fresenius Kabi is recalling specific lots of Ketorolac Tromethamine Injection because particulate matter was found in reserve sample vials.
Arrow International is recalling FlexTip Plus Epidural Kits because a rotatable collar on the filter may detach, causing a leak.
Genicon, Inc. is recalling Natura Model 210-105-251 cannulas because the plastic optical tip may detach from the metal shaft.
RaySearch Laboratories is recalling RayStation 9A software due to errors in dose calculation algorithms that could underestimate radiation therapy doses.
Blue Bird is recalling 2019-2021 Vision school buses because steering drag link connections may not be tightened, risking loss of control.
Blue Bird is recalling 2020 Vision buses because steering drag link connections may not be tightened correctly, potentially causing loss of steering control.
BMW and Toyota are recalling specific 2019-2020 models because a steering tie rod may fracture, increasing crash risk. Dealers will replace the parts free of charge.
Mazda is recalling 2020 Mazda3 and CX-30 vehicles because front brake caliper mounting bolts may not have been tightened properly, which could reduce braking performance.
Mazda is recalling 2020 CX-30 all-wheel drive vehicles because a disconnected fuel hose may leak, increasing fire and crash risks.
Airstream is recalling 2017-2018 Basecamp travel trailers because the entry door window adhesive may fail, allowing glass to detach and become a projectile.
Dana Incorporated is recalling certain heavy vehicle output shafts that may not have been properly heat treated, posing a risk of shaft fracture and detachment.
FCA US LLC is recalling 2014-2017 Jeep Cherokee vehicles due to a defect in the Power Transfer Unit that may cause loss of drive or Park function.
Chrysler is recalling specific Two-Speed Power Transfer Units for Jeep Cherokee vehicles because worn splines can cause a loss of drive or Park function, increasing crash risk.
Vermeer is recalling 2020 BC1200XL and BC1500 wood chippers because wheel lug nuts may loosen, allowing the wheel to detach and increasing crash risk.
Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants due to reports of inadequate locking of extended tab screws and post-operative backing out of the closure top.
Zimmer Biomet is recalling Vital MIS Spinal Fixation system implants because reports indicate the extended tab screws may not lock adequately, causing the closure top to back out after surgery.
Gillig is recalling 2018-2020 Low Floor buses because rear suspension lower control rods may fail, increasing crash risk.