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.
Cardinal Health is recalling approximately 414,194 units of its insulated gel pack because the product should not be used on infants or neonates. The company will update product labeling with a clear warning.
Access Vascular recalls 79 HydroPICC catheter kits because included scalpel and StatLock components have earlier expiration dates than stated on the package.
Cardinal Health is recalling 1,209,260 INSULATED GEL PACK REUSABLE, LARGE units because the product is not safe for infants or neonates. The company is adding a warning label.
Ferno-Washington is recalling 1,922 FERNO POWER X1 ambulance cots with 36V Li-Ion batteries that may become unstable and pose a fire or burn injury risk if dropped, power washed, or abused.
Cardinal Health is recalling 409,738 reusable gel pack units because they should not be used on infants or neonates. The company is adding a caution statement to labeling.
JLM Manufacturing LLC is recalling JLM Sesame Sticks Mix (11oz tubs) because units may contain undeclared cashew, a common allergen. The recall affects 307 cases distributed across 18 states.
Cardinal Health is recalling approximately 1.9 million reusable gel packs (Cat. 61115) because the product should not be used on infants or neonates. A caution statement is being added to the product labeling.
Cardinal Health is restricting use of 567,475 reusable hot and cold gel packs (Model M) on infants and neonates due to thermal injury risk. Updated labeling will warn against use on this vulnerable population.
Avanos Medical is recalling sterile extension sets distributed without expiration dates. Without proper dating, healthcare providers cannot verify sterility assurance, creating a potential patient safety risk.
Canon Aplio ultrasound systems may fail to properly terminate the Stress Echo protocol, potentially causing patient images to be assigned to wrong patients or not saved. This could delay diagnosis and treatment.
Sedecal Soltus battery mobile x-ray systems may move without operator command. The FDA is recalling 155 units distributed across the U.S. due to this safety hazard.
JLM Sunflower Meat Roasted/Salted is recalled for undeclared cashew allergen affecting 175 cases across 18 states. Consumers with tree nut allergies should not consume.
Medtronic is recalling MiniMed 630G and 670G insulin pumps due to a cybersecurity vulnerability that could allow unauthorized access to the pump system, potentially resulting in incorrect insulin delivery.
Beaver Arthro-Lok surgical blades may have been configured to curve right instead of left. If used during surgery, the incorrect curve could cause unintended tissue damage.
Cardinal Health recalls approximately 649,213 insulated gel packs due to contraindication for infants and neonates. Labeling will be revised with a caution statement.
Rama Food Manufacture Corp is recalling Pad Thai Noodles (lot 1128A1, manufactured 09/26/22) due to improper cooling and refrigeration during manufacturing. The products may pose a health risk.
Shyft Group is recalling 2022 Utilimaster Aeromaster vehicles because the side-view image may display the wrong side of the vehicle when the turn signal and brake are applied simultaneously.
Rieckhoff Family Businesses is recalling Gourmet Old-Fashioned Caramel Holiday Popcorn boxes because the label falsely claims the product is gluten-free, though it contains wheat and barley.
Ford is recalling 2021-2022 F-150 vehicles because the front windshield wiper motor may fail, reducing visibility and increasing crash risk.
Tesla is recalling certain 2023 Model 3 and 2020-2023 Model Y vehicles because taillights may intermittently fail to illuminate. A failed taillight reduces vehicle visibility and increases crash risk; Tesla is providing a free over-the-air software update.
Volvo Bus is recalling 2023 9700 vehicles because incorrectly installed emergency light sensors may prevent lights from activating after a rollover.
Tesla is recalling certain 2021-2023 Model X vehicles because a software calibration error in the restraint control module may prevent the front passenger airbag from deploying correctly during crashes, increasing injury risk.
Daimler Trucks North America is recalling 2021-2023 Thomas Built Buses Minotour school buses because the forward seat barrier may not provide sufficient protection, increasing injury risk in a crash.
Indian is recalling 2021-2022 Scout and Chief motorcycles for fuel pump failure that may cause engine stall while riding. Dealers will replace the fuel pump and seal free of charge.
Mockingbird Single-to-Double Strollers may have cracks in the frame that pose a fall risk to children. The manufacturer has received 138 reports of frame cracks, including 8 injuries, and is offering free frame reinforcement kits.