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.
Biomerieux Inc. recalled 2 units of BIOBALL A.BRASILIENSIS NCPF 2275 reference standard (Batch 7112) after temperature and time storage conditions exceeded acceptable ranges. The manufacturer cannot guarantee product performance.
Biomerieux Inc is recalling VITEK 2 Reagent NH Test Kit units nationwide because they were stored outside proper temperature and time parameters. Product performance cannot be guaranteed.
Biomerieux Inc is recalling the BIOBALL P.AERUGINOSA NCTC 12924 quality control product due to temperature and time excursions that may affect product performance. Two units with batch number 7240 were distributed nationwide.
Biomerieux Inc is recalling PPM Lombard Products IRR Count-Tact 3P Agar because storage conditions exceeded acceptable temperature and time parameters, potentially compromising product performance.
Biomerieux Inc. is recalling PPM Lombard TSA culture medium nationwide due to storage temperature excursion. The product may not perform to specification.
Biomerieux is recalling BIOBALL B.SPIZIZENII NCTC 10400 (Catalog 56012) microbiological test cultures because storage temperature and time conditions were exceeded, and product performance cannot be guaranteed.
Biomerieux Inc recalls GENE-UP Salmonella 2 reagent (Batch 1009407250) after storage temperature and time limits were exceeded, preventing performance guarantee.
XO Marshmallow Limited Edition Banana Puddin' OMG is being recalled for missing product labels on packaging. The recall affects 526 retail units distributed in 27 U.S. states and internationally.
Acumed LLC is recalling Acutrak bone screws and fusion devices distributed without FDA pre-market clearance. Patients should contact their healthcare provider for guidance.
Wismettac Asian Foods is recalling Premium Quality Shirakiku Fish Sausage Jalapeno because the casing contains undeclared bovine collagen. The product was distributed across 23 U.S. states.
Acumed is recalling Acutrak 2 bone screw products distributed without FDA pre-market clearance. Healthcare providers should contact Acumed or the FDA for guidance regarding use and management of these devices.
Apotex Corp. is recalling Timolol Maleate Ophthalmic Solution 0.5% (lot TA4844) nationwide due to failed stability specifications showing excessive weight loss that may affect medication potency.
Wismettac Asian Foods recalls Shirakiku Fish Sausage due to undeclared collagen (bovine dermis) casing. Approximately 4,780 units were distributed across multiple U.S. states.
Young Dental Manufacturing has recalled Denticator PICK-A-DENT intradental picks due to mislabeling. The recall affects 600 packs distributed in Iowa, New York, Pennsylvania, Tennessee, Texas, and Canada.
It'll Be Pizza is recalling Take 2 frozen pizza dough products (1,678 cases) distributed across Maine, Vermont, Massachusetts, Pennsylvania, and New Hampshire due to possible contamination with foreign debris from packaging.
Howmedica Osteonics is recalling Tobra bone cement because packaging instructions lack Turkish language translation, though the instructions themselves are accurate. The recall affects 20 units distributed internationally.
Howmedica Osteonics Corp. is recalling Full Dose CE Simplex P Single Bone Cement because the included instructions for use lack Turkish language translations. The product content itself is accurate; only the language translation is missing.
GE Healthcare is recalling certain B105P patient monitors because they may display inaccurate CO2 measurements when used in locations not at or near sea level with mmHg or kPa units selected.
Neuroquell Plus, a homeopathic calendula oil drug, has been voluntarily recalled due to current good manufacturing practice (cGMP) deviations. The recall affects 461 bottles distributed nationwide and in Australia.
DeRoyal Industries is recalling 36 kits of the LAMI/CRANI PACK (lot numbers 56219159 and 56593562, expiring 4/1/2026) distributed across 23 US states. This is a voluntary Class II device recall; the specific reason was not disclosed in available documentation.
STRADIS HEALTHCARE dental procedure trays may have incompletely sealed outer bags that could compromise sterility. The recall affects units distributed nationwide in the US and Canada.
DeRoyal Industries initiated an ongoing voluntary Class II recall of 204 kits of the DeRoyal CARDIAC LINEN PACK distributed to 23 U.S. states.
DeRoyal Industries is voluntarily recalling 440 kits of its Cataract Pack (Model 89-8650.10, Lot 55749537). The FDA classified this as a Class II device recall, but the specific reason is not provided in the notice.
DeRoyal SPINE PACK kits have been recalled because they contain 3M Health Care Steri Drapes components that have been previously recalled. Affected units should not be used.
DeRoyal Industries initiated a voluntary recall of 75 genitourinary (GU) pack kits (Lot 55971461, exp. 5/1/2024). The specific reason for recall is not disclosed in available FDA documentation.