[ 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 |
|---|---|---|---|---|
| 2026-06-24 | Class II | GE Medical Systems, LLCZ-2476-2026 | GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury. | — |
| 2026-06-24 | Class II | Medline Industries, LPZ-2437-2026 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | Risk Management & CAPA |
| 2026-06-24 | Class II | Steris CorporationZ-2448-2026 | There is a potential for paint delamination (chipping/peeling) on the lighting system's light heads. | — |
| 2026-06-24 | Class I | ARROW INTERNATIONAL, LLCZ-2392-2026 | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. | Environmental Monitoring |
| 2026-06-24 | Class II | Merit Medical Systems, Inc.Z-2517-2026 | Due to unsealed portions of pouches. | — |
| 2026-06-24 | Class II | Medline Industries, LPZ-2481-2026 | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. | Validation & Qualification |
| 2026-06-24 | Class II | Medline Industries, LPZ-2482-2026 | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. | Validation & Qualification |
| 2026-06-24 | Class II | Medline Industries, LPZ-2495-2026 | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. | Validation & Qualification |
| 2026-06-24 | Class II | Medline Industries, LPZ-2484-2026 | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. | Validation & Qualification |
| 2026-06-24 | Class II | Medline Industries, LPZ-2486-2026 | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. | Validation & Qualification |
| 2026-06-24 | Class II | Medline Industries, LPZ-2440-2026 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | Risk Management & CAPA |
| 2026-06-24 | Class I | Datex-Ohmeda IncZ-2357-2026 | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient. | — |
| 2026-06-24 | Class II | ConMed CorporationZ-2468-2026 | Potential for overpressure alerts. | — |
| 2026-06-24 | Class II | ConMed CorporationZ-2473-2026 | Potential for overpressure alerts. | — |
| 2026-06-24 | Class II | Medline Industries, LPZ-2485-2026 | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. | Validation & Qualification |
| 2026-06-24 | Class I | ARROW INTERNATIONAL, LLCZ-2379-2026 | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. | Environmental Monitoring |
| 2026-06-24 | Class II | Medline Industries, LPZ-2489-2026 | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. | Validation & Qualification |
| 2026-06-24 | Class II | Medline Industries, LPZ-2433-2026 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | Risk Management & CAPA |
| 2026-06-24 | Class II | Medline Industries, LPZ-2417-2026 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | Risk Management & CAPA |
| 2026-06-24 | Class II | Medline Industries, LPZ-2505-2026 | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. | Validation & Qualification |
| 2026-06-24 | Class II | Medline Industries, LPZ-2430-2026 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | Risk Management & CAPA |
| 2026-06-24 | Class I | ARROW INTERNATIONAL, LLCZ-2391-2026 | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. | Environmental Monitoring |
| 2026-06-24 | Class II | Medline Industries, LPZ-2427-2026 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | Risk Management & CAPA |
| 2026-06-24 | Class II | Medline Industries, LPZ-2429-2026 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | Risk Management & CAPA |
| 2026-06-24 | Class II | Medline Industries, LPZ-2414-2026 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | 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.