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.
X-Gen Pharmaceuticals is recalling Nystatin Topical Powder due to the potential presence of plastic particles. The recall covers 9,816 bottles distributed nationwide.
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS Poly Screws because they are not consistent with Quality System Requirements.
Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS MISS/MIS Tapper 7.5 mm due to non-compliance with Quality System Requirements.
Valorem Surgical is recalling 2,225 Pallas M/MAXIMIS 250mm Straight Rods because they are not consistent with Quality System Requirements.
Valorem Surgical LLC is recalling 262 units of Pallas M/MAXIMIS Nut Drivers because they are not consistent with Quality System Requirements.
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS MIS Pedicle Screws because they are not consistent with Quality System Requirements.
International Medsurg Connection is recalling 54.2 million piston syringes and hypodermic needles because the company lacks documentation to support the products' sterility claims.
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 350 Straight Rods because the devices are not consistent with Quality System Requirements.
Elekta, Inc. is recalling iGUIDE Software 2.2 because it contains incorrect PEC values. The software is used for patient positioning in radiotherapy environments.
Valorem Surgical LLC is recalling 262 units of the Pallas M/MAXIMIS MIS Tapper 5.5mm because the devices are not consistent with Quality System Requirements.
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Rod Benders because they are not consistent with Quality System Requirements. The devices are used for spinal fixation.
Valorem Surgical LLC is recalling 262 Pallas M/MAXIMIS Rod Benders because they are not consistent with Quality System Requirements.
International Medsurg Connection is recalling 54.2 million hypodermic needles because the company lacks sufficient documentation to support the products' sterility claims.
Valorem Surgical LLC is recalling 2,225 Pallas M/MAXIMIS 70mm Curved Rods due to non-compliance with Quality System Requirements.
Apace KY LLC is recalling 1,483 cartons of Amantadine HCl Capsules because they were mislabeled and contain Cyclobenzaprine HCl tablets instead.
Dr. Reddy's Laboratories is recalling specific lots of Pravastatin Sodium tablets because they failed impurity specifications.
Stryker Neurovascular is recalling 43 Stroke Fast Packs because the carton sleeve labels did not match the physical contents inside the packs.
Quidel Corporation is recalling InflammaDry sample collectors because in-house testing found plastic spurs at the tips of some units.
Bayer HealthCare is recalling Alka-Seltzer Gold effervescent tablets because customer complaints confirmed small holes or cracks in the foil of the blister packs.
Threshold Enterprises Ltd is recalling Planetary Herbals Ginseng Classic tablets because they were released before quality control testing confirmed negative results for coliform growth.
Teva Pharmaceuticals USA is recalling 28,188 bottles of Famotidine 20 mg tablets because they failed tablet weight specifications.
Sentinel CH SPA is recalling MULTIGENT Creatinine (Enzymatic) reagents because Reagent 1 may cause quality control values to shift out of acceptable range.
Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed to meet dissolution specifications.
Xintec Corp is recalling OptiLITE laser surgery products because reprocessing instructions may not meet new standards for cleaning and sterilization.
Stryker Neurovascular is recalling 48 Stroke Fast Packs because the pre-printed carton sleeve contents did not match the physical items inside.