[ 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 |
|---|---|---|---|---|
| 2026-04-01 | Class I | Erbe USA IncZ-1568-2026 | Probes may rupture/burst during activation | — |
| 2026-04-01 | Class I | Merit Medical Systems, Inc.Z-1575-2026 | 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 | I.T.S. GmbHZ-1602-2026 | 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-1607-2026 | 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-1642-2026 | 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 II | I.T.S. GmbHZ-1599-2026 | 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 III | Philips Ultrasound, IncZ-1626-2026 | 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-1597-2026 | 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 I | Erbe USA IncZ-1566-2026 | Probes may rupture/burst during activation | — |
| 2026-04-01 | Class II | I.T.S. GmbHZ-1605-2026 | 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 I | Philips Respironics, Inc.Z-1616-2026 | 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 I | Philips Respironics, Inc.Z-1617-2026 | 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 | I.T.S. GmbHZ-1606-2026 | 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 | Orthalign, IncZ-1630-2026 | Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) | Validation & Qualification |
| 2026-04-01 | Class II | Orthalign, IncZ-1629-2026 | Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) | Validation & Qualification |
| 2026-04-01 | Class II | Olympus Corporation of the AmericasZ-1639-2026 | 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 II | Waldemar Link GmbH & Co. KG (Mfg Site)Z-1652-2026 | 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 | I.T.S. GmbHZ-1604-2026 | 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 III | Philips Ultrasound, IncZ-1624-2026 | 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-1622-2026 | 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-1594-2026 | 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 I | Merit Medical Systems, Inc.Z-1578-2026 | 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 | I.T.S. GmbHZ-1593-2026 | 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-1638-2026 | 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 II | AMO Puerto Rico Manufacturing, Inc.Z-1634-2026 | Due to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as consistently as expected. | — |
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.