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.
Palmer Natural Products is recalling 723 bottles of unapproved Piracetam and Choline capsules sold online and in four states.
Advanced Sterilization Products is recalling STERRAD 100NX Sterilization Systems because they may emit unusual odors into the surrounding environment.
Teva Pharmaceuticals is recalling specific lots of Clonazepam orally disintegrating tablets because they failed content uniformity specifications.
Tri-Union Seafoods is voluntarily recalling Chicken of the Sea tuna cans because the lid seams do not meet quality standards.
Battenfeld Technologies is recalling Compact and Large handgun security vaults because the combination locks can fail, allowing unintended access to the contents.
Chu Minh Corp is recalling fresh and fried tofu products because they were produced in a facility without available hot water.
Arrow International is recalling Berman Angiographic Catheters because the instructions reference a discontinued contrast medium. The firm is updating the labeling.
Siemens is recalling Dimension Phosphorus reagent cartridges because they can cause falsely low creatinine results when processed near open wells.
Becton Dickinson is recalling BD Vacutainer Urinalysis Transfer Straw Kits due to incorrect polybag labeling that may cause users to mistake the tube for a culture and sensitivity tube.
Tri-Union Seafoods is voluntarily recalling Chicken of the Sea tuna cans because the lid seams do not meet quality standards.
Palmer Natural Products is recalling Oxiracetam & Choline capsules because they were marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical safety issues.
Zyno Medical LLC is recalling 2,589 Z-800 Volumetric Infusion Systems to update the Preventative Maintenance schedule and add software to monitor fluid volume.
Chu Minh Corp is recalling fresh and fried tofu products because they were produced in a facility without available hot water.
Palmer Natural Products is recalling Aniracetam & Choline capsules because they were marketed without an approved NDA or ANDA.
Siemens Medical Solutions is recalling COHERENCE RT Therapist software versions due to performance defects and non-critical safety issues identified during final system testing.
Roche Diagnostics is recalling certain lots of cobas x 480 reagent reservoirs because a missing separation may cause pipetting errors, leading to delayed results and wasted reagent.
Kroger is recalling Tender Twist Wheat Bread in 20 oz and 22.5 oz bags due to the discovery of plastic pen pieces and visible ink traces.
Palmer Natural Products is recalling Brain Defogger capsules because they were marketed without FDA approval. The product was sold in Florida, Idaho, California, and Hong Kong.
Bumble Bee International is voluntarily recalling specific lots of 5-ounce Chunk Light Tuna in Water because the products do not meet the company's standards for seal tightness.
Ferring Pharmaceuticals is recalling 126 injectors of TEV-TROPIN because the cartons are labeled for Needle-Free Head B but contain Needle-Free Head A.
Beckman Coulter is recalling Access Immunoassay Systems because a defective belt pulley creates debris that may cause erroneous test results.
Kroger is recalling Tender Twist 100% Whole Wheat Bread because visible ink and plastic pen pieces were found in the product.
Siemens is recalling COHERENCE RT Therapist software versions to address performance defects and safety issues identified during final system testing.
CareFusion 213, LLC is recalling 544,500 FREPP/SEPP kits because the product is not sterile, but the labeling misleadingly implies it is.