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.
General Motors is recalling 2018-2019 Chevrolet Silverado and GMC Sierra trucks because roof rail air bag inflators may rupture, posing an injury risk.
PandaEar is recalling about 9,700 portable hook-on chairs sold online because the crotch restraints can be removed without tools, allowing infants to fall through openings. No injuries have been reported.
Bethlehem Lights 10-inch Illuminated Ribbon Spheres are recalled because the LED lights can overheat and spark, posing a risk of serious injury or death from fire. About 2,000 units sold online through QVC from July 2024 to April 2026 are affected.
Lil Pick Up Inc. has recalled about 700 Sierra 125U Youth ATVs sold from October 2025 through April 2026 due to defects that violate federal safety standards and pose risks of serious injury or death, including suspension failures, faulty reverse lights, failing brakes, and hot surfaces.
ABC Trading is recalling WSDZ Light-up Shot Glasses because the button cell batteries can be easily accessed by children, creating an ingestion hazard that can cause serious internal injuries or death. No injuries have been reported.
Bentley is recalling 2026 Continental GT and GTC vehicles because an incorrect shorter front driveshaft may cause the hub nut to loosen, increasing crash risk.
General Motors is recalling specific 2015-2016 Cadillac models because the front-driver air bag inflator may rupture during deployment, potentially causing serious injury or death.
Hologic has recalled Selenia Dimensions Mammography Systems because internal bolts may become loose, missing, or broken over time. The company has received complaints of this issue affecting systems nationwide.
Arrow Edge Hemodialysis Catheterization Products are being recalled because they include a 16F splittable sheath introducer, subject to a supplier recall, that may not split as intended.
Medline Industries is recalling the Namic Angiographic Manifold (Product Number 64038402) because particulate matter has been found in the fluid path. This medical device is used in cardiopulmonary bypass procedures.
On-X Life Technologies is recalling the On-X Mitral Heart Valve with Conform-X Sewing Ring, Model ONXMC-25/33, because the valves were distributed before all required testing was complete, preventing confirmation that they meet all release specifications.
Stryker Sustainability Solutions is recalling 107 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging. The incomplete seals may compromise sterility assurance.
Medline is recalling 107 medical convenience kits containing Namic Manifold (TAVI) due to particulate found in the fluid path. The kits were distributed nationwide and internationally.
Omnicell is recalling rolls of label stock used in the i.v.Station automation device due to potential for mislabeled syringes during IV medication preparation and compounding.
Stryker Sustainability Solutions is recalling 90 units of the BARD Dynamic XT Deca Steerable electrophysiology catheter due to incomplete seals on the sterile product.
MICROVENTION INC. is recalling LVIS Intraluminal Support Devices due to dimensional nonconformance and incorrect device configuration that may result from manufacturing commingling, creating risk of vessel injury, thrombosis, or neurological events.
Medline Industries is recalling medical convenience kits (HEART CATH PACK-LF, Kit Number DYNJ36478B) due to particulate matter found in the fluid path of the Namic Manifold. Affected kits were distributed in the US and internationally.
Pure Ground Ingredients Organic Peppermint Leaf Powder, sold in wholesale bulk to tea and food manufacturers, is being recalled over potential Salmonella contamination.
Arrow International is recalling Arrow-Clark VectorFlow hemodialysis catheters due to a supplier defect in the sheath introducer that may fail to split properly, potentially causing withdrawal resistance, prolonged procedures, pain, bleeding, and tissue injury.
Medline Industries is recalling medical convenience kits containing Namic Manifolds due to particulate matter found in the fluid path. The recall affects three kit models distributed nationwide and internationally.
Arrow International is recalling NextStep Antegrade and Retrograde Hemodialysis Catheters worldwide because an included 16F dual-valved splittable sheath introducer may not split as intended, potentially causing pain, bleeding, hematoma, and tissue injury.
Arrow International is recalling Cannon II Plus Hemodialysis Catheters due to a defective sheath introducer that may not split properly, potentially causing withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, and tissue injury.
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product, which may compromise sterility.
Oasis Medical, Inc. is recalling Oasis Tears PF preservative-free lubricant eye drops nationwide due to lack of assurance of sterility following FDA observations during an inspection.
Toyota is recalling certain 2024 Tundra vehicles with the V35A engine because manufacturing debris may contaminate the engine and cause a main bearing to fail.