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.
Thor Motor Coach is recalling recreational vehicles from 2022-2024 because solar panel mounting brackets may become loose or break, allowing solar panels to detach and become road hazards.
Allura Imports is recalling about 120 youth sweatshirts with drawstrings due to risk of strangulation. The drawstrings can catch on objects and cause serious injury or death to children.
Svnntaa bed rails sold on Amazon violate safety standards and pose a risk of entrapment, asphyxiation, falls, and laceration. Consumers should stop using them immediately and contact Eokeanon for a refund.
Analemma Water Bottles are recalled because the inner glass liner can break, posing risk of serious injury or death from laceration and ingestion. The importer has received 20 reports of the glass breaking, including one oral injury.
Alcon Research LLC is recalling Systane Lubricant Eye Gel Night Gel (10g) distributed nationwide due to FDA inspection observations regarding lack of assurance of sterility that may impact product quality.
WHILL, INC. is recalling WHILL Model F powered wheelchairs with software versions before HMI 2.23 and MC 1.05 due to a Bluetooth Low Energy (BLE) communication vulnerability identified through the CISA Vulnerability Disclosure Program.
Boston Scientific is issuing a software update (Brady SMR6) for certain ACCOLADE and PROPONENT pacemakers and cardiac resynchronization therapy devices. The advisory population is expanding to include all dual-chamber extended life and CRT-P devices.
Beta Bionics is recalling iLet Bionic Pancreas units with software versions 1.4.2 and 1.4.3 due to a compatibility issue with Dexcom G7 sensors that can cause delayed glucose readings and loss of automatic insulin adjustments.
Immuno-Mycologics, Inc. is recalling Immy Myco DDR Trident Bulk Neutralization Buffer B (60 X 30 mL, Lot F5061154) because the product may contain contaminants. The buffer is used for clinical specimen processing for Mycobacterium spp. diagnosis.
North American Rescue LLC. is recalling AIDBAG first aid kits containing McKesson TRUE Metrix PRO blood glucose meters that display an E-5 error code incorrectly, potentially delaying appropriate patient treatment.
Boston Scientific is expanding a software advisory for ACCOLADE family pacemakers and cardiac resynchronization therapy devices. Updated software (Brady SMR6) is now available to address identified issues.
Medline is recalling multiple medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels that may render the product out-of-specification.
Scope Health is recalling Optase Dry Eye Intense Drops (Glycerin 0.2%) due to lack of assurance of sterility. The product is distributed nationwide.
Alcon Research LLC is recalling GenTeal Tears Lubricant Eye Gel nationwide due to FDA inspection observations indicating the product may lack assurance of sterility. Consumers should not use affected lots.
Medline Industries is recalling Medline and Centurion medical procedure kits containing neuro sponges due to higher-than-expected endotoxin levels that may cause the products to be out-of-specification.
Black-label enoki mushroom, lot 215, tested positive for Listeria monocytogenes. The product was distributed to accounts in California, Florida, and Maryland.
The second-row seat backs in certain 2021-2024 Toyota Highlander models may fail to lock into position during adjustment due to defective return springs. This could prevent proper occupant restraint during a crash.
The steering gear in certain 2025 International trucks may have cracks due to improper heat-treatment, which can cause loss of steering control and increase crash risk.
Stephan Baby Boo Bunnie toys are recalled because their plastic cube can break into small parts with sharp edges. CPSC received 20 reports of the cube breaking, including one where a child swallowed sharp pieces.
Thermos is recalling 8.2 million Stainless King and Sportsman food containers because stoppers can forcefully eject when the container pressurizes, causing impact and laceration injuries to consumers.
Angiodynamics is recalling the Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Medline Industries is recalling 41 different surgical kit models nationwide because regulatory clearances for certain control syringes, guidewires, and high-pressure tubing have been rescinded. Affected facilities should stop use and contact Medline.
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects multiple product SKUs distributed nationwide and internationally.
B. Braun Medical Inc. is recalling Sterile Water for Injection USP 3000 mL bags (24,928 units) distributed nationwide due to lack of assurance of sterility and potential leakage from the diaphragm port.
Medline Industries has recalled Control Syringes (Model DNSC89369 and DYNJSYR10C), Guidewires, and High-Pressure Tubing after their FDA 510(k) regulatory clearances were rescinded. The devices were distributed nationwide.