[ 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 |
|---|---|---|---|---|
| 2026-04-22 | Class I | B Braun Medical IncZ-1801-2026 | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. | — |
| 2026-04-22 | Class II | PHILIPS MEDICAL SYSTEMSZ-1825-2026 | Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing Go. 2. Potential where the message of Previous Surview Exists Select Previous Surview? <Yes> or <No> should display but does not appear. 3. After performing Surview and planning the Brain Helical acquisition by setting Brain Area DoseRight Index to increase the dose, there is the potential that the Define Head Area option in the context menu is grayed out. | — |
| 2026-04-22 | Class II | Siemens Medical Solutions USA, IncZ-1814-2026 | During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient. | — |
| 2026-04-22 | Class II | Medline Industries, LPZ-1824-2026 | On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile. | Environmental Monitoring |
| 2026-04-22 | Class I | B Braun Medical IncZ-1798-2026 | Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure. | — |
| 2026-04-15 | Class I | Medline Industries, LPZ-1721-2026 | 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 | Spacelabs Healthcare, Inc.Z-1793-2026 | Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload. | — |
| 2026-04-15 | Class II | Beckman Coulter, Inc.Z-1794-2026 | Due to manufacturing issue (incorrectly processing) with in vitro multidrug resistant test. | Documentation & Change Control |
| 2026-04-15 | Class II | Cook IncorporatedZ-1783-2026 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Validation & Qualification |
| 2026-04-15 | Class II | XTANT Medical Holdings, IncZ-1773-2026 | Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is. | Documentation & Change Control |
| 2026-04-15 | Class I | Medline Industries, LPZ-1719-2026 | 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-1778-2026 | 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-1713-2026 | 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-1716-2026 | 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-1714-2026 | 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-1720-2026 | 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-1785-2026 | 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-1784-2026 | 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-1791-2026 | 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-1780-2026 | 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-1728-2026 | 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-1712-2026 | 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-1777-2026 | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Validation & Qualification |
| 2026-04-15 | Class II | Brahms GmbHZ-1795-2026 | Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve. If Quality Controls are not performed according to the Instructions for Use, the underestimation of QC1 may go undetected and could contribute to falsely elevated sFlt-1/PlGF ratio results. A falsely elevated sFlt-1/PlGF ratio may result in a higher-risk classification for progression to preeclampsia with severe features potentially leading to intensified clinical monitoring. | Validation & Qualification |
| 2026-04-15 | Class II | Stryker Sustainability SolutionsZ-1804-2026 | Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure. | — |
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.