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.
Baxter is recalling DISCPAC syringe tip caps that are mislabeled as self-righting when they do not possess this capability, risking improper use in medical procedures.
Microbiologics Inc is recalling an inactivated Mycoplasma genitalium reference material (Catalog # HE0070N, Lot HE0070-01-1) because the quality control process did not meet specification requirements.
VIRGIN SCENT INC has recalled 46,368 bottles of artnaturals Hand Sanitizer nationwide due to manufacturing process deviations. The affected lots were produced using common ingredients from a contaminated batch.
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.
Siemens Healthcare Diagnostics is recalling Atellica CH Fructosamine reagent (lots 211359, 211451) due to potential reagent carryover that could affect diagnostic test accuracy.
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.
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.
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.
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.
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.
Philips is updating instructions for cleaning and disinfecting reusable autoclavable temperature probes due to revisions needed in the disinfection process.
Continental Mills voluntarily recalled 450 cases of Krusteaz Belgian Waffle Mix nationwide due to the presence of foreign materials.
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.
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.
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.
Ritedose is recalling 3,795 prefilled syringes of sodium chloride injection nationwide. The barcodes incorrectly identify the product as rocuronium bromide, creating a medication identification risk in healthcare settings.
Brius Technologies is recalling Brius Patient Specific Brackets that were sold before the company completed the required design control process and regulatory documentation.
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.
Macleods Pharma USA Inc is recalling Risedronate Sodium 5 mg tablets (Lot BRD2001A, expiration 5/2022) due to failed content uniformity specifications. The recall affects 4,872 bottles distributed nationwide.
Cook Medical recalled 24,641 Gunther Tulip Vena Cava Filter Sets due to updates required in the Instruction for Use documentation covering device description, indications, contraindications, warnings, and precautions.
DASH Pharmaceuticals is recalling Sucralfate Oral Suspension nationwide due to a labeling mix-up affecting approximately 45,940 unit dose cups.
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.
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.
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.