[ 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 |
|---|---|---|---|---|
| 2026-04-15 | Class I | Medline Industries, LPZ-1730-2026 | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. | — |
| 2026-04-08 | Class II | Intuitive Surgical, Inc.Z-1698-2026 | Due to increased complaints for broken/frayed grip cables for reusable instruments. | — |
| 2026-04-08 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-1672-2026 | 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-1738-2026 | 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 I | Philips Respironics, Inc.Z-1646-2026 | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. | — |
| 2026-04-08 | Class II | Medline Industries, LPZ-1708-2026 | 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-1755-2026 | Potential for attenuation degradation over time, decreasing the lifespan. | Validation & Qualification |
| 2026-04-08 | Class I | Philips Respironics, Inc.Z-1649-2026 | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. | — |
| 2026-04-08 | Class I | Philips Respironics, Inc.Z-1647-2026 | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. | — |
| 2026-04-08 | Class II | Stryker CommunicationsZ-1688-2026 | Surgical light assembly may not adequate support the weight of the ceiling cover. | — |
| 2026-04-08 | Class II | Mentor Texas, LP.Z-1683-2026 | Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break. | — |
| 2026-04-08 | Class II | Medtronic MiniMed, Inc.Z-1740-2026 | 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-1667-2026 | 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-1731-2026 | 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-1662-2026 | 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-1742-2026 | 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-1677-2026 | 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 | Olympus Corporation of the AmericasZ-1695-2026 | 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 | Medline Industries, LPZ-1706-2026 | 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-1670-2026 | 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 | Philips Respironics, Inc.Z-1648-2026 | In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths. | — |
| 2026-04-08 | Class I | Baxter Healthcare CorporationZ-1637-2026 | Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use. | — |
| 2026-04-08 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-1680-2026 | 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-1737-2026 | 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 | Intuitive Surgical, Inc.Z-1696-2026 | Due to increased complaints for broken/frayed grip cables for reusable instruments. | — |
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.