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.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH ReadyPack Assay kits because reagent and calibrator lots showed higher than anticipated variability.
Invatec Llc is recalling 177 Diver C.E. aspiration catheters because the labeled indications for use were not included in the existing regulatory clearance.
TG United, Inc. is recalling 348 bottles of AMBI cough syrup due to CGMP deviations resulting in underdosed products.
TG United, Inc. is recalling CPM / PSE Drops because the products are underdosed or have an incorrect dosage regime.
Nestle is recalling specific California Pizza Kitchen Crispy Thin Crust White pizzas because they may contain fragments of clear plastic.
TG United, Inc. is recalling 13,031 bottles of TL-Hist PD Drops because the product is underdosed or has an incorrect dosage regime.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH ReadyPack Assay kits because reagent and calibrator lots showed higher than anticipated variability.
The Compounding Shop is recalling Praziquantel 56.8 mg vials because FDA inspections raised concerns about quality control and sterility assurance.
TG United, Inc. is recalling 348 bottles of AMBI cough suppressant and expectorant due to CGMP deviations resulting in underdosed products.
Maytex Corp is recalling 43,915 cases of Comfort brand Ear-Loop Face Masks because lab testing showed they do not meet stated differential pressure standards and cannot be guaranteed as fluid resistant.
Stryker is recalling T4 XXL Toga products due to potential sterile barrier breaches in packaging identified during accelerated aging tests.
Intuitive Surgical is voluntarily recalling da Vinci 5 mm Flared Instrument Cannulae to implement a modified inspection process.
Stryker is recalling 2,000 units of T4 Toga surgical drapes due to potential sterile barrier breaches identified in accelerated aging tests.
Nestle USA is recalling specific DiGiorno Bianca pizzas due to potential clear plastic fragments. Consumers should check production codes and discard affected items.
Physicians Total Care is recalling Metronidazole Tablets, 500 mg, because some tablets may not conform to weight specifications. The recall covers 25,230 tablets distributed nationwide.
TG United, Inc. is recalling BroveX PSB Liquid antihistamine and decongestant products because they are underdosed or have an incorrect dosage regime.
Stryker is recalling 5,000 units of T4 Toga Zipper products due to potential sterile barrier breaches identified in accelerated aging tests.
Siemens Healthcare Diagnostics is recalling ADVIA Centaur iPTH Calibrators because the reagent and calibrator lots may have demonstrated higher than anticipated variability.
TG United, Inc. is recalling Mesehist DM cough and cold medicine because the product is underdosed or has an incorrect dosage regime.
Stryker is recalling T4 Toga pullovers because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Orthopedic Alliance LLC is recalling loaner bins and sterilization trays for orthopedic implants because directions for use and surgical techniques were not provided to every physician.
Orthopedic Alliance LLC is recalling 37 Bipolar Caps because directions for use and surgical techniques were not provided to every physician for every surgery.
Merit Medical Systems is recalling specific lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.
Spinal Solutions is recalling 35 loaner bins and sterilization trays because directions for use and surgical techniques were not provided to every physician.
Teva Pharmaceuticals is recalling Camrese oral contraceptives because an impurity called N-Butyl-Benzene Sulfonamide was detected during testing.