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.
Font Group of America Corp. is recalling ToYou Snacks Banana Foster bars due to undeclared soy allergen. Approximately 5,670 units were distributed in the United States.
Howmedica Osteonics Corp. is recalling Series II tibial bear inserts used in knee replacements. Raw material over 5 years old may have elevated oxidation levels, potentially affecting material properties.
Howmedica Osteonics Corp. is recalling certain knee replacement devices (product number 6637-0-931, lot 57403601) because raw material used in manufacturing may be over 5 years old, potentially causing elevated oxidation that affects device durability.
Howmedica is recalling SCORPIO TS knee implants made with raw material over 5 years old due to potential oxidation that could degrade the device's mechanical properties.
Howmedica Osteonics Corp. is recalling P7 28MM 10 DEGREE +4MM INSERT knee replacement components (Lot 61311701, 62122001) due to potential oxidation in aged UHMWPE material that could affect material properties.
Astor Chocolate Corp. has recalled Aldi Choceur Burnt Caramel Chocolate Bars due to undeclared coconut, a common allergen. The voluntary recall involves 1,092 units distributed to a distribution center in Florida.
Howmedica Osteonics is recalling TRIDENT 0 deg knee implant components manufactured with aged raw material that may have elevated oxidation levels, potentially affecting material properties.
Howmedica Osteonics is recalling tibial bearing inserts used in knee replacements manufactured from UHMWPE raw material over 5 years old. The material may develop elevated oxidation levels that could impact its structural properties.
Howmedica is recalling SCORPIO U-DOME PATELLA knee replacement implants manufactured with UHMWPE material over 5 years old due to potential elevated oxidation levels that could affect material properties.
Howmedica Osteonics Corp. is recalling Scorpio-Flex knee bearing inserts made with material over 5 years old that may develop oxidation affecting performance. Affected patients should contact their physician if they experience knee problems.
Howmedica Osteonics is recalling PS Lipped Tibial Insert knee replacement components manufactured with aged UHMWPE material that may develop oxidation, potentially affecting device properties and performance.
Philips is recalling Achieva 1.5T MRI scanners due to a seal adhesive defect on the body coil that may fail during scanning, creating sharp edges that risk skin injury including abrasions and lacerations.
Olympus is recalling 8,294 EZDilate Fixed Wire Balloon devices due to reports of device failures including bursting, leaking, and foreign body retention in patients undergoing esophageal dilation.
Howmedica Osteonics Trident knee replacement inserts manufactured with raw material over 5 years old may have elevated oxidation levels affecting material properties. This FDA Class II recall applies to Lot Number 29518001.
Howmedica Osteonics Corp. is recalling knee replacement implants manufactured with UHMWPE material over 5 years old. The aged material has potential for elevated oxidation levels, which could affect the implant's material properties.
Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee replacement implants manufactured with UHMWPE material over 5 years old. The aged material may develop elevated oxidation levels that could affect the implant's performance.
A Philips MRI coil component's adhesive may fail and create sharp edges that could injure patients during scanning. The defect affects 286 units worldwide.
Howmedica Osteonics Corp. is recalling SCORPIO Total Knee Concentric Dome Patella components due to potential oxidation in raw materials over 5 years old. No illnesses have been reported.
Den-Mat Holdings recalls OralProCare medicated lip treatment due to manufacturing quality control deviations that may affect product conformance to labeled specifications. No illnesses reported.
GE HealthCare is recalling certain IC9-RS intracavitary ultrasound probes due to a double image artifact that creates ghost images. This unrecognized artifact can lead to diagnostic errors.
AtriCure recalls certain tank hose assemblies for Cryo Module equipment due to manufacturing defects. The units have incorrect inner tube material and missing required perforations on the outer sheathing.
Howmedica Osteonics recalls SCORPIO U-DOME PATELLA knee components. Older UHMWPE raw material may have elevated oxidation, potentially affecting material properties.
Medline Industries is recalling certain blood culture kits due to a Bactec component with an expiration date not reflected on the kit insert. Users may unknowingly use an expired component if they do not check the Bactec itself.
Golden State Medical Supply Inc. is recalling 108 bottles of Budesonide Extended-Release Tablets (9 mg) distributed in Illinois due to failed dissolution specifications.
Win Luck Trading Inc recalled Tasty Snacks Plum Queen Dried Plums (7 ounce cans, code 12122023) because the product contains undeclared sulfites, a food allergen.