FDA Enforcement
US Food and Drug Administration enforcement data: drug/device/food recalls (including Class I most-serious), FAERS adverse-event reports, 510(k) medical device clearances, and Structured Product Labeling (drug labels with indications, warnings, dosage).
Data on hand
recent recalls
- Class II Hikma Pharmaceuticals USA INC. — drug (2026-08-24): Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
- Class II Olympus Corporation of the Americas — device (2026-08-18): Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
- Class II Dreyer's Grand Ice Cream Inc. — food (2026-08-18): Foreign object: products may contain glass pieces
- Class II Dreyer's Grand Ice Cream Inc. — food (2026-08-18): Foreign object: products may contain glass pieces
- Class II Dreyer's Grand Ice Cream Inc. — food (2026-08-18): Foreign object: products may contain glass pieces
- Class II Dreyer's Grand Ice Cream Inc. — food (2026-08-18): Foreign object: products may contain glass pieces
- Class II Dreyer's Grand Ice Cream Inc. — food (2026-08-18): Foreign object: products may contain glass pieces
- Class II Dreyer's Grand Ice Cream Inc. — food (2026-08-18): Foreign object: products may contain glass pieces
serious adverse events
- FAERS 26940054 (2026-06-30): ["Blood potassium increased","Glaucoma","Blood creatinine abnormal","Glomerular filtration rate incr
- FAERS 26940056 (2026-06-30): ["Warm autoimmune haemolytic anaemia"]
- FAERS 26940058 (2026-06-30): ["Seizure","Aspiration","Acute kidney injury","Metal poisoning","Drug-induced liver injury","Product
- FAERS 26940061 (2026-06-30): ["Dyspnoea","Hernia"]
- FAERS 26940065 (2026-06-30): ["Death","Product use issue"]
recent 510k clearances
- Paragon 28, Inc. — Primal K-Wire (P99-193-1410) (2026-08-28)
- Roche Molecular Systems, Inc. — cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas Strep A Quality Control Kit (07402678190) (2026-08-28)
- Reflow Medical, Inc. — Kiba CTO Crossing Catheter (2026-08-28)
- GE Healthcare Finland Oy — Carescape Canvas 1000; Carescape Canvas Smart Display (2026-08-28)
- Roche Molecular Systems, Inc. — cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System (07454945190); cobas® Cdiff Positive and Negative Control Kit for use on the cobas® Liat® System (07454970190) (2026-08-28)
Endpoints