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.
Glaxosmithkline is recalling Benefiber Healthy Shape Prebiotic Fiber Supplement because it may contain small plastic pieces.
Ivoclar Vivadent AG is recalling 639 units of IPS e.max ZirCAD ceramic blocks because they crack during the sintering process.
Sandoz is recalling 17,500 units of Infuvite Pediatric Multiple Vitamins Injection due to sub-optimal crimping in the vial. The product was distributed nationwide.
Inpeco S.A. is recalling 313 Siemens Aptio Automation Centrifuge Modules because a tube loading algorithm may cause unbalanced loads that could damage the centrifuge.
Northgate Technologies is recalling 9 FR AUTOLITH probes because a lot failed biocompatibility testing. The recall covers 298 boxes distributed nationwide.
ICU Medical is recalling 123 units of the Cogent Hemodynamic Monitoring System because a software issue prevents the system from storing patient IDs and information.
Ortho Development Corporation is recalling 29 tibial tray components due to a manufacturing defect that may cause assembly resistance.
Stryker is recalling 40 units of Neptune E-SEP 165mm Blade Electrodes shipped to Canada because they were expired due to a distribution error.
Smiths Medical ASD Inc. is recalling 100 units of Portex Lumbar Puncture Trays because the inner trays were mislabeled with an incorrect model number.
Rong Shing Trading NY Inc is recalling XinXing Dried Plum because the product contains dried peaches, which are not listed on the front label.
Siemens is recalling Atellica CH 930 Analyzers with specific software versions due to a defect that may cause incorrect test results.
Baxter Healthcare is issuing a Class II recall for 133 Prismaflex Systems to communicate safety information regarding the proper use of connectors.
Baxter Healthcare is recalling 555 Prismaflex Systems to communicate safety information regarding the proper use of connectors.
Baxter Healthcare is recalling 4,946 Prismaflex Systems to communicate safety information regarding the proper use of connectors.
Bio-Rad Labs is recalling 376 units of the Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA Test, Lot 18200A, due to elevated lot-to-lot bias affecting antibody measurements.
Obalon Therapeutics is recalling 45 Obalon Balloon Systems because the touchscreen may lose calibration, preventing balloon inflation.
Baxter issued a safety communication regarding the proper use of connectors with the Prismaflex System and Control Unit.
Boston Scientific is recalling 150 iLab Polaris and Ultrasound systems in Europe because a software bug prevents specific data from being archived without notifying the user.
Boston Scientific is recalling MoXy Laser Fibers to update instructions and reduce the likelihood of metal cap and fiber tip breakage.
Baxter is recalling 1,225 Prismaflex Systems to communicate safety information regarding the proper use of connectors.
Becton Dickinson is recalling 900 units of CareFusion Safe-T-Centesis Catheter Drainage Trays because the 8 Fr catheter was manufactured with a 6.9 Fr needle instead of the correct 8 Fr needle.
Boston Scientific is recalling 225 units of Sensor Nitinol Wire with Hydrophilic Tip due to increased complaints about difficulty tracking over the guidewire.
Boston Scientific is recalling Sensor Nitinol Wires with Hydrophilic Tips because an increased rate of complaints indicates difficulty tracking over the guidewire, which may cause procedural delays.
Rayner Intraocular Lenses Limited is recalling RaySert PLUS RSP01 injectors due to a mismatch between the outer and inner tray expiration dates and lot numbers.
Biomerieux Inc is recalling VITEK 2 Gram-positive Susceptibility Cards because they may produce false positive results for certain Staphylococcus aureus strains.