[ 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 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-1664-2026 | 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-1752-2026 | 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-1707-2026 | 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 | Burlington Medical, LLCZ-1761-2026 | Potential for attenuation degradation over time, decreasing the lifespan. | Validation & Qualification |
| 2026-04-01 | Class I | Navajo Manufacturing CompanyZ-1588-2026 | If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad under the body, then the high limit device is unable to sense the higher temperature so power is not terminated. May cause a burning smell prior to melting/burning potentially causing burns to persons and property. | — |
| 2026-04-01 | Class III | Philips Ultrasound, IncZ-1621-2026 | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Documentation & Change Control |
| 2026-04-01 | Class II | I.T.S. GmbHZ-1603-2026 | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | — |
| 2026-04-01 | Class II | Olympus Corporation of the AmericasZ-1612-2026 | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. | Risk Management & CAPA |
| 2026-04-01 | Class II | Tandem Diabetes Care, Inc.Z-1636-2026 | The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event. | Documentation & Change Control |
| 2026-04-01 | Class I | Merit Medical Systems, Inc.Z-1577-2026 | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access. | — |
| 2026-04-01 | Class II | Waldemar Link GmbH & Co. KG (Mfg Site)Z-1651-2026 | The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct. | — |
| 2026-04-01 | Class II | Medtronic MiniMed, Inc.Z-1635-2026 | Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery). | Data Integrity |
| 2026-04-01 | Class II | Olympus Corporation of the AmericasZ-1640-2026 | Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use. | Risk Management & CAPA |
| 2026-04-01 | Class III | Philips Ultrasound, IncZ-1623-2026 | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Documentation & Change Control |
| 2026-04-01 | Class III | Philips Ultrasound, IncZ-1627-2026 | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Documentation & Change Control |
| 2026-04-01 | Class II | CareFusion 303, Inc.Z-1645-2026 | Due to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi communication with Point-of-Care Units | Documentation & Change Control |
| 2026-04-01 | Class II | Olympus Corporation of the AmericasZ-1613-2026 | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. | Risk Management & CAPA |
| 2026-04-01 | Class I | Philips Respironics, Inc.Z-1615-2026 | Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient. | — |
| 2026-04-01 | Class II | GE Medical Systems, LLCZ-1590-2026 | There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position. | — |
| 2026-04-01 | Class III | Philips Ultrasound, IncZ-1625-2026 | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Documentation & Change Control |
| 2026-04-01 | Class II | Olympus Corporation of the AmericasZ-1643-2026 | Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use. | Risk Management & CAPA |
| 2026-04-01 | Class I | Merit Medical Systems, Inc.Z-1576-2026 | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access. | — |
| 2026-04-01 | Class II | Olympus Corporation of the AmericasZ-1610-2026 | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. | Risk Management & CAPA |
| 2026-04-01 | Class II | I.T.S. GmbHZ-1608-2026 | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | — |
| 2026-04-01 | Class II | I.T.S. GmbHZ-1598-2026 | Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU). | — |
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.