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.
About 3,500 children's robes made by HulovoX fail federal flammability standards for sleepwear and pose a burn injury risk. The robes were sold online through Amazon.com from January to May 2021 for about $30 each.
Medshape is recalling DYNANAIL MINI surgical nails due to manufacturing defect in lot 04882. Affected endcaps may not seat flush during surgical insertion, potentially affecting implant integrity.
Joy's International Foods is recalling Joy's Gourmet Blast Off! Bloody Mary Mix (24 oz) due to undeclared fish and soy allergens. Consumers with allergies to these ingredients should not consume the product.
Abbott Molecular is recalling 742 Alinity m System units worldwide due to a software issue that prevents Field Service Engineers from properly completing maintenance and diagnostics procedures.
Siemens is recalling Atellica CH 930 clinical chemistry analyzers with software v1.25.1 or lower. Two software defects could cause inaccurate test results: test parameters may revert to defaults, or the analyzer may use expired reagents.
Some Invacare AVIVA FX power wheelchairs with LiNX Gyro firmware 6.1.2 may decelerate more aggressively than programmed, creating injury risk.
Uromedica is recalling nonsterile implantation instrument sheaths (Lot UM00794 and UM00817) because the U-channel sheaths may damage ProACT implant devices during implantation procedures. Affected devices were distributed nationwide.
Flower Orthopedics is recalling 48 units of the Flex-Thread Inserter Shaft due to mating incompatibility with the Inserter Draw Rod. The defect may cause the draw rod to bind during fibula intramedullary nail insertion, potentially preventing surgery completion.
Giant Bicycle Inc. is recalling about 20,800 units of 2021 Model Year Giant and Liv adult bicycles because the adjustable handlebar stem can become loose, posing fall and injury hazards. The company has received 86 reports of loose handlebars, including three reports of riders falling.
Howmedica Osteonics Corp. is recalling Triathlon Pro Tibial Preparation Trays that may contain the wrong surgical instrument. The incorrect component could delay surgery or cause unintended bone preparation during knee replacement procedures.
Abbott Molecular is recalling 742 Alinity m System diagnostic devices worldwide due to potential for abnormal amplification curves that could affect test accuracy.
Medtronic is recalling the Abre Venous Self-Expanding Stent System due to reports of stent migration. Approximately 21,653 devices were distributed nationwide and internationally.
The DBB-06 Hemodialysis Delivery System was distributed without required FDA premarket approval. Approximately 781 units were shipped to healthcare facilities in multiple states.
Invacare AVIVA Storm RX power wheelchairs with firmware version 6.1.2 may decelerate more aggressively than programmed, risking user injury.
Play-Mor is recalling specific 2017-2020 trailers because a propane regulator may fail, increasing pressure and fire risk. Dealers will replace the parts free of charge.
Inclinator Company of America is recalling residential elevators manufactured from 1979 through 2021 because young children can become entrapped between the exterior landing door and interior elevator car door, risking serious injury or death.
Oshkosh is recalling 2019-2022 S-Series vehicles because fuel tubes may crack, causing high-pressure leaks that increase fire risk.
Reading Truck Body is recalling 2017-2021 Marauder Landscape Dump Body vehicles because a rear pivot mount weld may fail, increasing injury risk.
Forest River is recalling 2021-2022 Aurora and Catalina travel trailers because the panel sealing the cooktop from the furnace was not properly sealed, which could cause an inverted flame and fire risk.
Forest River, Inc. is recalling certain 2021-2022 fifth wheel trailers equipped with defective Sailun tires that may experience belt separation. The defect could cause loss of vehicle control and increase the risk of a crash.
Polaris is recalling about 1,100 Model Year 2022 Outlaw 110 EFI Youth ATVs because the inner layer of the fuel line can leak, posing a fire hazard. No fires or injuries have been reported.
Kettle River Products is recalling approximately 1,464 pounds of chicken alfredo pizza due to misbranding and an undeclared wheat allergen. No adverse reactions have been reported.
Colony Brands is recalling about 20 covered wood wagons sold through Montgomery Ward's and Ginny's from September to October 2021 because paint on the wood, plastic handles, and red plastic cover contains excessive lead that can be toxic if ingested by young children.
The Model B35200 Percept PC Neurostimulator may become unresponsive during cardioversion procedures when circuit electronics are damaged. Affected patients should contact their healthcare provider.
Siemens recalled 13 ARTISTE linear accelerator systems for cancer treatment due to a potential safety issue that could cause radiation to be delivered to the wrong treatment site.