[ FDA ENFORCEMENT INTELLIGENCE ]
Learn from the record. Every FDA recall is a quality signal.
Live drug, device & food recall data from the FDA (openFDA enforcement) — food spanning dietary supplements, cosmetics & animal food — mapped to the GxP quality domains SPEQ assesses, so you can see where control breaks down across every regulated industry.
1,000
Total recalls
217
Class I (most serious)
167
Drug
515
Device
318
Food / supplement / cosmetic
Last 12 months · latest report 2026-07-22 · source: openFDA enforcement
RECALLS BY CLASSIFICATION · MONTHLY
RECALL REASONS BY QUALITY DOMAIN
Domain mapping is a SPEQ interpretation of the FDA recall reason, not an official FDA classification.
409 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2568-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2573-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | Acumed LLCZ-2532-2026 | Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use. | Risk Management & CAPA |
| 2026-07-01 | Class II | Zimmer, Inc.Z-2527-2026 | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. | Risk Management & CAPA |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2557-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | Amgen, Inc.D-0613-2026 | CGMP Deviations | Risk Management & CAPA |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2570-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2563-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2564-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | Amgen, Inc.D-0616-2026 | CGMP Deviations | Risk Management & CAPA |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2566-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2560-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | Zimmer, Inc.Z-2531-2026 | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. | Risk Management & CAPA |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2555-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2565-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | Ajanta Pharma USA IncD-0611-2026 | CGMP Deviations | Risk Management & CAPA |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2569-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2567-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | SURGIFY MEDICAL OYZ-2562-2026 | Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). | Risk Management & CAPA |
| 2026-07-01 | Class II | Zimmer, Inc.Z-2529-2026 | Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. | Risk Management & CAPA |
| 2026-06-24 | Class II | Dabur India LimitedD-0635-2026 | CGMP Deviations; deficiencies observed during FDA inspection | Risk Management & CAPA |
| 2026-06-24 | Class II | Dabur India LimitedD-0633-2026 | CGMP Deviations; deficiencies observed during FDA inspection | Risk Management & CAPA |
| 2026-06-24 | Class II | Dabur India LimitedD-0631-2026 | CGMP Deviations; deficiencies observed during FDA inspection | Risk Management & CAPA |
| 2026-06-24 | Class II | Dabur India LimitedD-0642-2026 | CGMP Deviations; deficiencies observed during FDA inspection | Risk Management & CAPA |
| 2026-06-24 | Class II | Dabur India LimitedD-0629-2026 | CGMP Deviations; deficiencies observed during FDA inspection | Risk Management & CAPA |
Data: U.S. FDA openFDA enforcement API. Quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Recall details are as reported by the FDA.