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.
Dr. Reddy's is recalling Zenatane (isotretinoin) capsules because some lots failed to meet dissolution specifications, potentially affecting drug absorption.
Teleflex Medical is recalling 1,150 Hudson RCI Pediatric Nasal Cannulas because the box label says 'Pediatric' while the insert says 'Adult'.
Nexstim PLC is recalling 21 units of the Navigated Brain Stimulation System due to a software defect that may generate duplicate files.
Dr. Reddy's Laboratories is recalling Zenatane (isotretinoin) capsules because some lots failed to meet dissolution specifications.
Cook Medical is voluntarily recalling 335 LapSac Introducer Sets because the provided reprocessing instructions lack sufficient detail for proper cleaning, disinfection, and sterilization.
Cook Medical is voluntarily recalling Willscher Vas Reapproximator Plates because the reprocessing instructions lack sufficient detail for cleaning, disinfection, and sterilization.
Qualgen is recalling Estradiol 10 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 5,260 pellets distributed nationwide.
HEB is recalling Hill Country Fare and Good Bread wheat bread products due to the presence of rubber in the product.
Qualgen is recalling Estradiol 20 mg pellets due to CGMP deviations and lack of quality assurance. The recall covers 4,468 pellets distributed nationwide.
Chrysler is recalling 2017 Pacifica Plug-in Hybrid vehicles because the tire placard incorrectly lists seating capacity and weight limits, potentially causing vehicle overloading.
Exact Sciences is recalling 15 Sample Mixer 2 units in Wisconsin due to door damage incidents caused by the Sample Holder lid.
Trident Seafoods is recalling frozen Alaska Cod Diamond Cut Squares because they may contain small pieces of plastic.
Roche Diagnostics is recalling 1,603 units of Elecsys PreciControl Varia 3 because the e-barcode and value sheet contain a typographical error for PTH target values.
AbbVie is recalling specific lots of PEG Kits due to potential defects including missing components, duplicate parts, or missing labels and instructions.
Trident Seafoods is recalling Panko Breaded Alaska Cod because it may contain small pieces of plastic.
Toshiba is recalling 70 Angio WorkStation units because the Peak Skin Dose value may display incorrectly if the workstation is powered on after the Infinix system.
Siemens is recalling certain lots of SHBG Immulite 2000 reagents because they may not meet stability claims, potentially causing test bias.
Trident Seafoods is recalling frozen Alaska Cod Rectangles because they may contain small pieces of plastic.
Medtest Holdings is recalling Pointe Scientific Lactate Dehydrogenase Reagent Sets because the product's stability claim is not being met.
Cell Marque is recalling CD117, c-kit reagents because they were not labeled 'For Export Only' as required by the FD&C Act.
Acumed LLC is voluntarily removing the Slide-Loc Anatomic Radial Head System from the market due to complaints about instrumentation performance, trial design, and implant dissociations.
VistaPharm is recalling Nystatin Oral Suspension because it contains an impurity peak that exceeds approved specifications.
Zimmer Biomet is voluntarily recalling 16 units of the Modular Hybrid Glenoid Base Large after two pieces with quality defects were shipped.
Trident Seafoods is recalling frozen breaded cod products because they may contain small pieces of plastic. The recall affects 7 cases distributed across 26 states.
AbbVie is recalling 3,331 PEG kits distributed in the US and 31 other countries because they may have missing components, duplicate parts, or missing labels.