[ 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 |
|---|---|---|---|---|
| 2026-04-08 | Class II | Mentor Texas, LP.Z-1687-2026 | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | — |
| 2026-04-08 | Class II | Burlington Medical, LLCZ-1764-2026 | Potential for attenuation degradation over time, decreasing the lifespan. | Validation & Qualification |
| 2026-04-08 | Class II | Reflexion Medical, Inc.Z-1656-2026 | Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose. | Data Integrity |
| 2026-04-08 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-1663-2026 | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | — |
| 2026-04-08 | Class II | Burlington Medical, LLCZ-1758-2026 | Potential for attenuation degradation over time, decreasing the lifespan. | Validation & Qualification |
| 2026-04-08 | Class II | Medtronic MiniMed, Inc.Z-1743-2026 | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. | — |
| 2026-04-08 | Class II | Medtronic MiniMed, Inc.Z-1741-2026 | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. | — |
| 2026-04-08 | Class II | Burlington Medical, LLCZ-1756-2026 | Potential for attenuation degradation over time, decreasing the lifespan. | Validation & Qualification |
| 2026-04-08 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-1674-2026 | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | — |
| 2026-04-08 | Class II | Medtronic MiniMed, Inc.Z-1751-2026 | All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. | — |
| 2026-04-08 | Class II | Intuitive Surgical, Inc.Z-1700-2026 | Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments | — |
| 2026-04-08 | Class II | Ultradent Products, Inc.Z-1689-2026 | Composite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment. | — |
| 2026-04-08 | Class II | Medline Industries, LPZ-1710-2026 | Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure. | — |
| 2026-04-08 | Class II | ReCor Medical Inc.Z-1655-2026 | Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. | — |
| 2026-04-08 | Class II | Civco Medical Instruments Co. Inc.Z-1735-2026 | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. | Documentation & Change Control |
| 2026-04-08 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-1671-2026 | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | — |
| 2026-04-08 | Class II | Medline Industries, LPZ-1690-2026 | Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may also occur if user over-tightens the connector to stop the leakage, including additional clinical intervention, risk of infection, patient discomfort, and prolonged recovery process. | Risk Management & CAPA |
| 2026-04-08 | Class II | Intuitive Surgical, Inc.Z-1699-2026 | Due to increased complaints for broken/frayed grip cables for reusable instruments. | — |
| 2026-04-08 | Class II | Burlington Medical, LLCZ-1760-2026 | Potential for attenuation degradation over time, decreasing the lifespan. | Validation & Qualification |
| 2026-04-08 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-1665-2026 | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | — |
| 2026-04-08 | Class II | Burlington Medical, LLCZ-1759-2026 | Potential for attenuation degradation over time, decreasing the lifespan. | Validation & Qualification |
| 2026-04-08 | Class II | Mentor Texas, LP.Z-1682-2026 | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | — |
| 2026-04-08 | Class II | Burlington Medical, LLCZ-1753-2026 | Potential for attenuation degradation over time, decreasing the lifespan. | Validation & Qualification |
| 2026-04-08 | Class II | Intuitive Surgical, Inc.Z-1697-2026 | Due to increased complaints for broken/frayed grip cables for reusable instruments. | — |
| 2026-04-08 | Class I | Abiomed, Inc.Z-1589-2026 | Increased risk of purge leaks with Generation 1 purge cassettes. | — |
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.