[ 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 |
|---|---|---|---|---|
| 2026-06-17 | Class II | Avanos Medical, Inc.Z-2335-2026 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Environmental Monitoring |
| 2026-06-17 | Class II | DT MedTech, LLCZ-2399-2026 | Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left implant packaging and labeling bears a right implant device. | Documentation & Change Control |
| 2026-06-17 | Class II | Avanos Medical, Inc.Z-2346-2026 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Environmental Monitoring |
| 2026-06-17 | Class II | Avanos Medical, Inc.Z-2348-2026 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Environmental Monitoring |
| 2026-06-17 | Class II | Avanos Medical, Inc.Z-2343-2026 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Environmental Monitoring |
| 2026-06-17 | Class II | Avanos Medical, Inc.Z-2337-2026 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Environmental Monitoring |
| 2026-06-17 | Class II | Avanos Medical, Inc.Z-2338-2026 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Environmental Monitoring |
| 2026-06-17 | Class II | INSPIREMD IncZ-2325-2026 | Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. | — |
| 2026-06-17 | Class II | ICU Medical, Inc.Z-2312-2026 | Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery. | — |
| 2026-06-17 | Class II | INSPIREMD IncZ-2326-2026 | Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. | — |
| 2026-06-17 | Class II | GE Medical Systems, LLCZ-2314-2026 | GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON. | — |
| 2026-06-17 | Class II | Boston Scientific Neuromodulation CorporationZ-2402-2026 | Reusable electrodes may not meet expected performance levels. | — |
| 2026-06-17 | Class II | Fresenius Medical Care Holdings, Inc.Z-2401-2026 | There is an error in the labeling of the GTIN on the product. When scanned; however, the case labeling, lot number, and printed labeling on the product correctly identifies the product code and the solution contained in the bag. In the event the incorrect GTIN labeling is used as the singular source for product identification, unrecognized use of a potassium solution with a concentration differing from the prescription may result. | Documentation & Change Control |
| 2026-06-17 | Class II | Avanos Medical, Inc.Z-2339-2026 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Environmental Monitoring |
| 2026-06-17 | Class II | Avanos Medical, Inc.Z-2344-2026 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Environmental Monitoring |
| 2026-06-17 | Class II | ICU Medical, Inc.Z-2311-2026 | Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery. | — |
| 2026-06-17 | Class II | Mozarc Medical US LLCZ-2319-2026 | The Tegaderm CHG dressing, as specified in product labeling, was missing from certain lots of Mahurkar Elite PASS Trays. | Documentation & Change Control |
| 2026-06-17 | Class II | AVID Medical, Inc.Z-2410-2026 | Inadvertent distribution of sealed pouches that had not undergone validated sterilization. | Environmental Monitoring |
| 2026-06-17 | Class II | Inter-Med LlcZ-2400-2026 | Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case of ingestion, while the correct Aluminum Chloride insert instructs users not to induce vomiting. | Documentation & Change Control |
| 2026-06-17 | Class II | Avanos Medical, Inc.Z-2340-2026 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Environmental Monitoring |
| 2026-06-17 | Class II | INSPIREMD IncZ-2330-2026 | Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. | — |
| 2026-06-17 | Class II | INSPIREMD IncZ-2328-2026 | Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. | — |
| 2026-06-17 | Class II | BERLIN HEART GMBHZ-2320-2026 | Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures. | Validation & Qualification |
| 2026-06-17 | Class II | Boston Scientific Neuromodulation CorporationZ-2403-2026 | Reusable electrodes may not meet expected performance levels. | — |
| 2026-06-17 | Class II | Boston Scientific CorporationZ-2413-2026 | Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking. | Environmental Monitoring |
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.