[ 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 II | I.T.S. GmbHZ-1601-2026 | 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 | Straumann USA LLCZ-1632-2026 | A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06. | Documentation & Change Control |
| 2026-04-01 | Class II | Olympus Corporation of the AmericasZ-1611-2026 | 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 | Merit Medical Systems, Inc.Z-1579-2026 | 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 I | Philips Respironics, Inc.Z-1614-2026 | 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 | Medline Industries, LPZ-1650-2026 | Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result. | Environmental Monitoring |
| 2026-04-01 | Class II | I.T.S. GmbHZ-1600-2026 | 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-1620-2026 | 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-1641-2026 | 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 | Beckman Coulter, Inc.Z-1609-2026 | Due to the likely presence of contamination in well(s). | Environmental Monitoring |
| 2026-04-01 | Class II | I.T.S. GmbHZ-1592-2026 | 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-1567-2026 | Probes may rupture/burst during activation | — |
| 2026-04-01 | Class III | Philips Ultrasound, IncZ-1619-2026 | To provide clarification and labelling to define the useful life of ultrasound transducers in the field. | Documentation & Change Control |
| 2026-04-01 | Class II | Koven Technology, Inc.Z-1631-2026 | Product labeling includes a fetal indication for use that is not cleared under its 510(k). | Documentation & Change Control |
| 2026-04-01 | Class II | Olympus Corporation of the AmericasZ-1644-2026 | 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-1596-2026 | 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-1628-2026 | 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-1618-2026 | 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-1595-2026 | 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 | Straumann USA LLCZ-1633-2026 | A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06. | Documentation & Change Control |
| 2026-03-25 | Class II | GE Medical Systems, LLCZ-1571-2026 | There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data. | Data Integrity |
| 2026-03-25 | Class II | Howmedica Osteonics Corp.Z-1572-2026 | A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment. | — |
| 2026-03-25 | Class II | Baxter Healthcare CorporationZ-1573-2026 | Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals. | — |
| 2026-03-25 | Class II | Abbott Diagnostics Scarborough, Inc.Z-1565-2026 | It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use. | — |
| 2026-03-25 | Class II | Hologic, Inc.Z-1586-2026 | Due to product exhibiting potential to generate either invalid or false negative results. | — |
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.