Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
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.
DNA Genotek Inc. is recalling ORAcollect RNA: ORE-100 kits due to evaporation of the stabilizing liquid, which reduces shelf life. Approximately 17,080 units are affected, including lot YJ530.
Siemens is recalling Artis zee floor MN X-ray systems due to a potential cooling circuit malfunction. If coolant drops below adequate levels, the X-ray tube may not cool properly and the system will automatically shut down.
Siemens Artis zee ceiling X-ray systems may fail to cool the X-ray tube if the coolant level drops. The system will automatically block X-ray emissions and display warning messages to prevent equipment damage.
DNA Genotek Inc. is recalling ORAcollect Dx oral DNA collection devices because the stabilizing liquid can evaporate, reducing shelf life and potentially affecting sample preservation.
Michelin is recalling specific Pilot Sport 4 ZP tires because they lack the required DOT certification symbol on the sidewall.
Norwex USA is recalling approximately 40,000 ceramic knives because the handles can break during use, creating a laceration hazard. The knives were distributed free as promotional items from January through February 2022.
Elite Comfort Solutions is recalling about 700 Nectar Premier Mattresses sold through nectarsleep.com from July to September 2021 because they fail to meet federal flammability standards, posing a fire hazard. No injuries have been reported.
Philips is updating instructions for cleaning and disinfecting reusable autoclavable temperature probes due to revisions needed in the disinfection process.
Preferred Pharmaceuticals is recalling Econazole Nitrate Cream 1% due to CGMP deviations. The manufacturer discontinued its stability study program; affected lots were distributed in California and Florida.
Continental Mills voluntarily recalled 450 cases of Krusteaz Belgian Waffle Mix nationwide due to the presence of foreign materials.
Siemens Healthcare Diagnostics is recalling Atellica CH Fructosamine reagent (lots 211359, 211451) due to potential reagent carryover that could affect diagnostic test accuracy.
Medline Industries is recalling Stanbio TDM/Beta-Hydroxybutyrate Linearity Standards due to improper storage controls that may affect test result timing. The recall affects 10 boxes distributed to healthcare facilities in six states.
Medline's Hydroxybutyrate LiquiColor Tests are recalled due to improper storage that may cause delayed test results. The recall affects 45 units distributed across 16 U.S. states.
Bio-Botanica is recalling NATURE's ANSWER Coral Calcium supplements because the product contained cesium chloride, a New Dietary Ingredient. The recall affects 6852 bottles distributed to 17 states.
Volcano Corp is recalling MM-TSM touch screen modules used with IntraSight Integrated IVUS systems because they may crack or become damaged, potentially rendering the imaging equipment non-functional.
Aurobindo Pharma USA Inc. is recalling 433,809 vials of Cyanocobalamin injection nationwide because assay testing showed the drug is subpotent, containing less than the specified 1,000 mcg/mL of active ingredient. Affected lots with specific expiration dates from September 2022 to April 2023 are identified for recall.
Triple E Recreational Vehicles is recalling 2021-2022 Wonder W24RL models because an incorrect weight decal may lead to overloading the storage compartment.
Telebrands is recalling four Hempväna pain relief products containing lidocaine because their packaging does not meet child-resistant requirements under the Poison Prevention Packaging Act, posing a poisoning risk to young children.
MTD Products is recalling about 6,200 Craftsman 30" Mini and Troy-Bilt TB30 riding lawn mowers because they can fail to stop completely and continue moving at about one mile per hour when the brake pedal is fully pressed.
Pfizer is recalling quinapril and hydrochlorothiazide tablets (20 mg/25 mg) nationwide due to elevated chemical impurities exceeding acceptable daily intake limits. No illnesses have been reported.
Brius Technologies is recalling Brius Patient Specific Brackets that were sold before the company completed the required design control process and regulatory documentation.
The YSIO X.Pree x-ray system's user interface displays incorrect collimation information during image acquisition. While actual collimation functions correctly, the display does not match preset parameters, potentially confusing operators.
Jubilant Cadista Pharmaceuticals is recalling Methylprednisolone Tablets USP 4mg because they contain less active ingredient than labeled. Lot 21 P0322 was distributed nationwide and in Puerto Rico.
Abbott is recalling 529 units of the Amplatzer Steerable Delivery Sheath (Class II) distributed outside the US due to an update to the device's instructions for use.
The Natural Dentist Healthy Breath Antiseptic Rinse (Cool Mint) is being recalled due to a label mix-up. The back label incorrectly states the active ingredient as Peppermint Oil and Sage Oil and displays the wrong UPC code.