[ 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 | Synthes (USA) Products LLCZ-1703-2026 | A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread. | Documentation & Change Control |
| 2026-04-08 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-1659-2026 | 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-1711-2026 | 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 | Medtronic MiniMed, Inc.Z-1744-2026 | 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 | ReCor Medical Inc.Z-1654-2026 | Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. | — |
| 2026-04-08 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-1692-2026 | Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence. | — |
| 2026-04-08 | Class II | Synthes (USA) Products LLCZ-1702-2026 | A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread. | Documentation & Change Control |
| 2026-04-08 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-1668-2026 | 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 | Mentor Texas, LP.Z-1681-2026 | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | — |
| 2026-04-08 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-1673-2026 | 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 | Civco Medical Instruments Co. Inc.Z-1733-2026 | 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-1676-2026 | 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-1705-2026 | 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 | Medtronic MiniMed, Inc.Z-1748-2026 | 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-1678-2026 | 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 | Mentor Texas, LP.Z-1684-2026 | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | — |
| 2026-04-08 | Class II | Civco Medical Instruments Co. Inc.Z-1736-2026 | 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 | BD KIESTRA LAB AUTOMATIONZ-1658-2026 | In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity. | Validation & Qualification |
| 2026-04-08 | Class II | GE Healthcare LLCZ-1767-2026 | Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury. | — |
| 2026-04-08 | Class II | Intuitive Surgical, Inc.Z-1701-2026 | Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments | — |
| 2026-04-08 | Class II | Medtronic MiniMed, Inc.Z-1745-2026 | 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 | Civco Medical Instruments Co. Inc.Z-1734-2026 | 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 | Medtronic MiniMed, Inc.Z-1749-2026 | 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-1757-2026 | Potential for attenuation degradation over time, decreasing the lifespan. | Validation & Qualification |
| 2026-04-08 | Class II | Mentor Texas, LP.Z-1685-2026 | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | — |
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.