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.
CryoLife, Inc. is recalling 52 On-X Prosthetic Heart Valves because the sewing ring type was mislabeled as Standard instead of Anatomic.
Correctional Industries Food Factory is recalling frozen vegan vegetable stew and black beans due to water contaminated with PFOA and PFOS chemicals.
Lyrical Foods is voluntarily recalling Kite Hill Almond Yogurt because some packages spoiled before the best-by date.
Correctional Industries Food Factory is recalling frozen turkey salami lunch trays because they were made with water contaminated with PFOA and PFOS chemicals.
Correctional Industries Food Factory is recalling frozen PBJ Lunch trays because they were made with water contaminated with PFOA and PFOS.
Natus Medical is recalling Olympic Pasteurmatic 3000 and 3500 systems because they do not fully meet current regulatory requirements due to design age and component obsolescence.
Correctional Industries Food Factory is recalling frozen white whole wheat bread ends made with water contaminated by PFOA and PFOS.
Correctional Industries Food Factory is recalling frozen whole grain banana bread muffins made with water contaminated by PFOA and PFOS.
Correctional Industries Food Factory is recalling frozen Whole Grain Pumpkin Bread Muffins because they were made with water contaminated with PFOA and PFOS.
Correctional Industries Food Factory is recalling frozen breakfast trays because they were made with water contaminated with PFOA and PFOS chemicals.
Morski Brands, Inc. is recalling Dawn's Foods Tropical Fruit Dip in Wisconsin due to undeclared Yellow #5 dye.
3CS Organics LLC is recalling specific Lebenswert infant and toddler milk formulas because the products are not FDA approved and lack full English labeling.
Correctional Industries Food Factory is recalling frozen vegan sloppy joe meals because they were made with water contaminated with PFOA and PFOS chemicals.
Correctional Industries Food Factory is recalling frozen Halal Chicken Bologna Lunch trays because they were made with water contaminated with PFOA and PFOS chemicals.
Ion Beam Applications is recalling Proteus 235 and Proteus ONE proton therapy systems because on-site software installations were not performed consistently with standard operating procedures.
Encore Medical is recalling 9 units of 3DKnee Tibial Inserts because a size 6 left box contained a size 8 right insert.
Exactech is recalling 928 Equinoxe Modular Reverse Pilot-Tip Starter Reamers to update instructions for use. The update clarifies proper reaming technique to prevent instrument breakage.
Exactech is recalling Equinoxe Glenoid Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.
Exactech is recalling Equinoxe Narrow Modular Reverse Pilot-Tip Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.
Mallinckrodt is recalling ArterX Surgical Sealant because improper labeling led to improper storage. The affected units were distributed to the UK.
Lantheus is recalling 26 doses of Fludeoxyglucose F 18 Injection in Puerto Rico because the product failed impurity specifications for acetonitrile residual solvent.
Medacta USA Inc. is recalling one lot of GMK Hinge Tibial Inserts because they are missing a screw required for attachment to the tibial base plate.
Exactech is recalling 382 Equinoxe Reverse Starter Reamers to update instructions for use, clarifying that off-axis reaming may cause instrument breakage.
Boston Scientific is recalling 32 units of Extractor Pro RX-S Retrieval Balloon Catheters because the labels incorrectly identify the injection location relative to the balloon.
Exactech, Inc. is recalling 573 Logic Fit Tibial Tamp Heads to update surgical labeling. The update clarifies proper removal techniques to prevent instrument breakage.