[ 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 | Burlington Medical, LLCZ-1765-2026 | Potential for attenuation degradation over time, decreasing the lifespan. | Validation & Qualification |
| 2026-04-08 | Class II | Mentor Texas, LP.Z-1686-2026 | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | — |
| 2026-04-08 | Class II | Medline Industries, LPZ-1691-2026 | 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 | Medtronic MiniMed, Inc.Z-1750-2026 | 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 | Medline Industries, LPZ-1693-2026 | There is a potential breach in the sterile pouch packaging for one lot of radiology kits, which may compromise product sterility. | Environmental Monitoring |
| 2026-04-08 | Class II | SUMMA THERAPEUTICS, LLCZ-1704-2026 | Potential for the balloon in the device to not meet burst specifications. | — |
| 2026-04-08 | Class II | Siemens Healthcare Diagnostics, Inc.Z-1657-2026 | A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and magnitude of the negative bias and imprecision increase over time and are not consistent with the assay Instructions For Use (IFU). When this issue is present, Quality Control (QC) results demonstrate a negative trend and increased imprecision. The clinical impact of a negative (A1c_E) bias may lead to a delay in diagnosis for diabetes or lead to less-than-optimal treatment for existing diabetes. | Validation & Qualification |
| 2026-04-08 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-1660-2026 | 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-1763-2026 | Potential for attenuation degradation over time, decreasing the lifespan. | Validation & Qualification |
| 2026-04-08 | Class II | Olympus Corporation of the AmericasZ-1694-2026 | Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additionally, smoke or a burning smell may occur. By design, the issue causing the smoke or burning smell would be contained within the internal laser console enclosure and would be self-extinguishing. | — |
| 2026-04-08 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-1666-2026 | 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-1746-2026 | 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-1754-2026 | Potential for attenuation degradation over time, decreasing the lifespan. | Validation & Qualification |
| 2026-04-08 | Class II | Burlington Medical, LLCZ-1762-2026 | Potential for attenuation degradation over time, decreasing the lifespan. | Validation & Qualification |
| 2026-04-08 | Class II | Civco Medical Instruments Co. Inc.Z-1732-2026 | 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 | Oxoid Australia Pty LimitedZ-1766-2026 | Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells. | Environmental Monitoring |
| 2026-04-08 | Class II | Medline Industries, LPZ-1709-2026 | 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 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-1679-2026 | 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 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-1669-2026 | 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 I | Abiomed, Inc.Z-1591-2026 | Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps. | — |
| 2026-04-08 | Class II | Medtronic MiniMed, Inc.Z-1747-2026 | 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 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-1661-2026 | 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 | Cardinal Health 200, LLCZ-1768-2026 | The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes. | Documentation & Change Control |
| 2026-04-08 | Class II | Medtronic MiniMed, Inc.Z-1739-2026 | 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 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-1675-2026 | Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch. | — |
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.