[ 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 |
|---|---|---|---|---|
| 2026-05-06 | Class II | Philips North AmericaZ-1952-2026 | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | — |
| 2026-05-06 | Class II | Philips North AmericaZ-1967-2026 | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | — |
| 2026-05-06 | Class II | DEPUY (IRELAND)Z-1990-2026 | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Environmental Monitoring |
| 2026-05-06 | Class II | Philips North AmericaZ-1966-2026 | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | — |
| 2026-05-06 | Class II | Philips North AmericaZ-1965-2026 | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | — |
| 2026-05-06 | Class II | Medline Industries, LPZ-2034-2026 | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | Environmental Monitoring |
| 2026-05-06 | Class II | Medline Industries, LPZ-2013-2026 | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | Environmental Monitoring |
| 2026-05-06 | Class II | Hologic, IncZ-1949-2026 | It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducted to restore affected system to the validated configuration and reinforce proper use in accordance with the Operator's Manual. | — |
| 2026-05-06 | Class II | Medline Industries, LPZ-2037-2026 | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | Environmental Monitoring |
| 2026-05-06 | Class II | Philips North AmericaZ-1959-2026 | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | — |
| 2026-05-06 | Class I | WHILL, INC.Z-1827-2026 | Cyber vulnerability of BLE communication was found by CISA VDP program. | — |
| 2026-05-06 | Class II | Advanced Bionics, LLCZ-1950-2026 | The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery. | Risk Management & CAPA |
| 2026-05-06 | Class II | Philips North AmericaZ-1963-2026 | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | — |
| 2026-05-06 | Class I | North American Rescue LLC.Z-1947-2026 | Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error, which can lead to operator confusion when evaluating patients and a delay in appropriate treatment. This is a downstream recall of Trividia Health Class I, Recall Event ID 98317. | — |
| 2026-05-06 | Class II | Medline Industries, LPZ-2008-2026 | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | Environmental Monitoring |
| 2026-05-06 | Class II | Becton Dickinson & Co.Z-1982-2026 | BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification. | — |
| 2026-05-06 | Class II | Philips North AmericaZ-1954-2026 | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | — |
| 2026-05-06 | Class II | Philips North AmericaZ-1961-2026 | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | — |
| 2026-05-06 | Class II | Medline Industries, LPZ-2021-2026 | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | Environmental Monitoring |
| 2026-05-06 | Class II | Merit Medical Systems, Inc.Z-2004-2026 | catheter may experience resistance when being advanced over the guidewire | — |
| 2026-05-06 | Class II | Medline Industries, LPZ-2024-2026 | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | Environmental Monitoring |
| 2026-05-06 | Class II | Philips North AmericaZ-1951-2026 | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | — |
| 2026-05-06 | Class II | Medline Industries, LPZ-2026-2026 | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | Environmental Monitoring |
| 2026-05-06 | Class II | Straumann USA LLCZ-1994-2026 | Includes an incorrect screw seat interface. | Documentation & Change Control |
| 2026-05-06 | Class III | Heraeus Medical GmbH (Dental Division)Z-1998-2026 | Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months). | Validation & Qualification |
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.