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.
Padagis US LLC is recalling Gynazole 1 butoconazole nitrate vaginal cream nationwide due to a manufacturing error where hydrophilic colloidal silica was used instead of hydrophobic colloidal silica.
Nature's Path Organic Pumpkin Spice Waffles are being recalled due to undeclared peanut allergen. About 6,908 cases were distributed across 17 states.
Cosmedent is recalling the FlexiCup Composite Finishing & Polishing System due to reports that the elastomer cup material is crumbling. Approximately 7,400 packs distributed worldwide are affected.
Corin Ltd is recalling Unity Total Knee System inserts due to a labeling mix-up between batches 529803 and 532405, potentially affecting size 6 and size 7 designations.
Nature's Path Organic Dark Chocolate Chip Waffles are recalled because peanuts were not declared on the label, posing a risk to consumers with peanut allergies.
Randox Laboratories is recalling the RX Daytona Plus (without ISE) IVD Clinical Chemistry Analyzer due to a flaw in rerun settings that may cause incorrect test result reporting.
Nova Biomedical's Stat Profile Prime Plus POC analyzer may report inaccurate creatinine results during the first 2-4 hours after sensor cartridge installation. Standard quality control checks may not detect these errors.
Siemens Medical Solutions USA is recalling 367 mobile X-ray systems (186 Cios Flow and 181 Cios Spin) due to a software issue that may result in patient misdiagnosis and repeat radiation exposure. Affected units were distributed nationwide.
Pepsi Beverages is recalling Crush Orange Soda 24-packs due to plastic foreign material found in some cans. The recall affects 184 cases distributed in Minnesota with lot code JUL2924XXXXMC10243 and a best-by date of July 29, 2024.
Rise Baking Company is recalling Favorite Day Bakery demi French bread sold at Target due to plastic contamination. The affected bread poses a choking hazard and was distributed in California and Iowa.
Cepheid is recalling Xpert Xpress Strep A test kits because pipettes may fail to dispense adequate sample volume, potentially resulting in invalid or absent test results.
Sun Pharmaceutical is recalling approximately 2,304 bottles of Liothyronine Sodium Tablets, USP, 25 mcg (lot DNC2204A) due to failed impurity and degradation specifications. The affected medication was distributed nationwide.
MicroVention is recalling 14 units of the AZUR CX 35 Peripheral Coil System due to unsealed pouch packaging that could compromise device sterility. The affected units were distributed across eight states.
GlaxoSmithKline is recalling TUMS Antacid (1000mg Calcium Carbonate) due to the presence of glass mineral wool. The affected lot (HV6B) was distributed nationwide.
RX Imola-IVD Clinical Chemistry Analyzers may report test results incorrectly when handling out-of-range samples due to improper parameter rerun settings. 35 units nationwide are affected.
Randox Laboratories is recalling the RX Modena-IVD Clinical Chemistry Analyzer nationwide due to parameter re-run settings that may fail to function correctly when samples are outside the assay range, potentially resulting in incorrect test results.
Coapt LLC is recalling the Dome Electrode Gen2 system due to potential burns or blistering from exposure to sunlight, warm temperatures exceeding 12 hours, or battery damage.
Sun Pharmaceutical is recalling 7,392 bottles of Liothyronine Sodium Tablets (Lot DND0058A) nationwide due to failed impurity and degradation specifications. Patients should contact their healthcare provider.
Nova Biomedical Prime Plus Analyzers may report incorrect creatinine levels during the first 2-4 hours after installing a new sensor cartridge. These errors may not be identified by traditional quality control practices.
Randox Laboratories is recalling 13 RX Monaco-IVD Clinical Chemistry Analyzers with a rerun feature defect that may report incorrect test results when samples are outside normal assay range. Units were distributed nationwide including Puerto Rico.
Select Custom Solutions is recalling JayRobb Vanilla Flavored Egg White Protein Powder due to plastic contamination. Approximately 1,008 pouches distributed nationwide are affected.
GlaxoSmithKline is recalling TUMS Antacid 1000 mg chewable tablets in Assorted Berries flavor due to glass mineral wool contamination found in some bottles. Product was distributed nationwide.
Siemens Cios Alpha (VA30) C-arm X-ray systems have a software issue that may not meet updated DIN and IEC standards. This defect could result in patient misdiagnosis or unnecessary repeat imaging.
Prevost is recalling 2022-2024 H3-45 and H3-45 VIP vehicles because the right front turn signal light may fail when activated. Inoperative turn signals and hazard lights reduce visibility to other drivers and increase crash risk.
Gulf States Toyota is recalling 195 2023 Toyota RAV4 vehicles equipped with 17" black alloy wheels. The tire valve stems may be improperly installed or damaged, potentially causing air leakage, underinflation, and crash risk.