[ 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.
1,158 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-04-15 | Class II | Siemens Medical Solutions USA, IncZ-1653-2026 | During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements. | — |
| 2026-04-15 | Class II | Cook IncorporatedZ-1789-2026 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Validation & Qualification |
| 2026-04-15 | Class II | Cook IncorporatedZ-1788-2026 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Validation & Qualification |
| 2026-04-15 | Class II | Cook IncorporatedZ-1775-2026 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Validation & Qualification |
| 2026-04-15 | Class I | Medline Industries, LPZ-1718-2026 | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | — |
| 2026-04-15 | Class II | Cook IncorporatedZ-1790-2026 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Validation & Qualification |
| 2026-04-15 | Class I | Medline Industries, LPZ-1715-2026 | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | — |
| 2026-04-15 | Class II | Beckman Coulter, Inc.Z-1772-2026 | Due to a manufacturing issue - missing a drug in well 4/4 but contain double the amount of antibiotics | Risk Management & CAPA |
| 2026-04-15 | Class I | Medline Industries, LPZ-1723-2026 | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | — |
| 2026-04-15 | Class II | Molded Products IncZ-1774-2026 | Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of the threaded sleeve not being engaged and becoming un-attached. | Environmental Monitoring |
| 2026-04-15 | Class II | Tornier, IncZ-1769-2026 | Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system. | Documentation & Change Control |
| 2026-04-15 | Class II | Cook IncorporatedZ-1779-2026 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Validation & Qualification |
| 2026-04-15 | Class II | Cook IncorporatedZ-1786-2026 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Validation & Qualification |
| 2026-04-15 | Class II | Cook IncorporatedZ-1781-2026 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Validation & Qualification |
| 2026-04-15 | Class I | Medline Industries, LPZ-1722-2026 | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | — |
| 2026-04-15 | Class II | Cook IncorporatedZ-1787-2026 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Validation & Qualification |
| 2026-04-15 | Class II | Cook IncorporatedZ-1776-2026 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Validation & Qualification |
| 2026-04-15 | Class I | Medline Industries, LPZ-1729-2026 | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | — |
| 2026-04-15 | Class I | Medline Industries, LPZ-1727-2026 | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | — |
| 2026-04-15 | Class I | Medline Industries, LPZ-1725-2026 | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | — |
| 2026-04-15 | Class II | Cook IncorporatedZ-1792-2026 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Validation & Qualification |
| 2026-04-15 | Class I | Medline Industries, LPZ-1717-2026 | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | — |
| 2026-04-15 | Class I | Medline Industries, LPZ-1724-2026 | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | — |
| 2026-04-15 | Class II | Cook IncorporatedZ-1782-2026 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Validation & Qualification |
| 2026-04-15 | Class I | Medline Industries, LPZ-1726-2026 | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | — |
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.