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 is recalling three Artis zee angiographic x-ray systems due to a software fault that prevents the system from initializing after a tube assembly failure.
Instradent USA is recalling 170 Neodent CM Intraoral Scanbodies because the body diameter is incompatible with CM Implants when positioned subcrestally.
Smith & Nephew is recalling 19 units of D-RAD locking pegs because the expiration dates on the labels are incorrect and later than the actual dates.
Zimmer Dental Inc is recalling 188 units of the Tapered SwissPlus Implant System because the internal thread diameter is below specification.
Smith & Nephew is recalling specific Peri-Loc VLP self-tapping cortex screws because the expiration dates printed on the labels are incorrect and later than the actual dates.
Ace Surgical Supply Co., Inc. is recalling 87 INFINITY Internal Hex Healing Abutments because the incorrect device was packaged.
2k Innovations Inc. is recalling 22,757 Volt Resistance Heated Neck Garments because FDA inspections found the firm made unapproved therapy and medical claims on product information and its website.
Boston Scientific is recalling Imager II Angiographic Catheters because some packages are mislabeled as Contra 2 curve catheters when they contain Contra curve catheters.
Jubilant Cadista Pharmaceuticals is recalling Bupropion Hydrochloride Extended-release Tablets because they failed impurity specifications.
2k Innovations is recalling Volt Resistance Heated Slippers because FDA inspections found the company made unapproved therapy and medical claims on product information and its website.
The FDA is recalling bulk Estradiol Non-Micronized, USP, manufactured by Qinhuangdao Zizhu Pharmaceutical, Co. due to cGMP deviations and lack of quality assurance.
Classik Foods Inc. is voluntarily recalling Maggi 2 Minute Noodles in Florida and Georgia due to misbranding. No illnesses have been reported.
Ortho-Clinical Diagnostics is recalling VITROS NT-proBNP Reagent Packs because background signals are increasing, causing calibration failures.
Medisca, Inc. is recalling Estradiol, USP Bulk (Hemihydrate) in 25 g and 100 g bottles due to cGMP deviations identified during an FDA inspection.
2k Innovations Inc. is recalling 22,757 Volt Resistance Heated Therapy Shoulder Wraps because the firm made unapproved therapy and medical claims on product information and its website.
Citron Pharma LLC is recalling 420 bottles of Penicillin V Potassium 500 mg tablets because Amoxicillin 500 mg tablets were found in the bottles.
Zimmer Biomet is recalling MEDTECH ROSA Spine 1.0.2 software because an unapproved change was made by the supplier. The device is used to guide instruments during spine surgery.
Qinhuangdao Zizhu Pharmaceutical is recalling Estradiol Micronized Bulk for prescription compounding due to cGMP deviations and lack of quality assurance.
McKesson Medical Surgical is recalling 98 vials of Hydralazine Hydrochloride Injection because some were stored refrigerated instead of at room temperature.
GE Healthcare is recalling 118 units of Centricity PACS Web Diagnostic software due to a defect where study category labels and hanging positions appear incorrectly swapped.
Medisca, Inc. is recalling Estriol, USP (Micronized) Bulk in various bottle sizes due to cGMP deviations identified during an FDA inspection.
2k Innovations is recalling Volt Resistance Heated Socks because FDA inspections found the product makes unapproved therapy and medical claims.
2k Innovations Inc. is recalling 22,757 Volt Resistance Heated Therapy Foot Wraps because FDA inspections found unapproved therapy and medical claims on product information and the company website.
Merit Medical Systems is recalling 1,940 PreludeSYNC Radial Compression Devices because manufacturing particulates may prevent the inflation valve from sealing completely.
The FDA is recalling bulk levonorgestrel manufactured by Qinhuangdao Zizhu Pharmaceutical due to cGMP deviations and lack of quality assurance.