[ 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 |
|---|---|---|---|---|
| 2026-06-24 | Class II | Medline Industries, LPZ-2431-2026 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | Risk Management & CAPA |
| 2026-06-24 | Class II | Medline Industries, LPZ-2429-2026 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | Risk Management & CAPA |
| 2026-06-24 | Class II | Medline Industries, LPZ-2505-2026 | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. | Validation & Qualification |
| 2026-06-24 | Class II | Medline Industries, LPZ-2446-2026 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | Risk Management & CAPA |
| 2026-06-24 | Class I | ARROW INTERNATIONAL, LLCZ-2386-2026 | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. | Environmental Monitoring |
| 2026-06-24 | Class II | ConMed CorporationZ-2466-2026 | Potential for overpressure alerts. | — |
| 2026-06-24 | Class II | Thoratec LLCZ-2518-2026 | Due to 11 volt Backup Battery failures. | — |
| 2026-06-24 | Class II | ConMed CorporationZ-2471-2026 | Potential for overpressure alerts. | — |
| 2026-06-24 | Class I | ARROW INTERNATIONAL, LLCZ-2385-2026 | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. | Environmental Monitoring |
| 2026-06-24 | Class II | Medline Industries, LPZ-2438-2026 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | Risk Management & CAPA |
| 2026-06-24 | Class II | Thoratec LLCZ-2519-2026 | Due to 11 volt Backup Battery failures. | — |
| 2026-06-24 | Class II | Medline Industries, LPZ-2436-2026 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | Risk Management & CAPA |
| 2026-06-24 | Class I | ARROW INTERNATIONAL, LLCZ-2396-2026 | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. | Environmental Monitoring |
| 2026-06-24 | Class I | ARROW INTERNATIONAL, LLCZ-2368-2026 | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. | Environmental Monitoring |
| 2026-06-24 | Class II | Medline Industries, LPZ-2486-2026 | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. | Validation & Qualification |
| 2026-06-24 | Class I | ARROW INTERNATIONAL, LLCZ-2371-2026 | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. | Environmental Monitoring |
| 2026-06-24 | Class I | Abiomed, Inc.Z-2457-2026 | Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support. | — |
| 2026-06-24 | Class I | ARROW INTERNATIONAL, LLCZ-2391-2026 | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. | Environmental Monitoring |
| 2026-06-24 | Class II | Staar Surgical AGZ-2509-2026 | Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses. | — |
| 2026-06-24 | Class II | Howmedica Osteonics Corp.Z-2461-2026 | Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB). | Documentation & Change Control |
| 2026-06-24 | Class II | Medline Industries, LPZ-2416-2026 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | Risk Management & CAPA |
| 2026-06-24 | Class I | Abiomed, Inc.Z-2360-2026 | Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices. | Data Integrity |
| 2026-06-24 | Class II | AMD Medicom Inc.Z-2458-2026 | Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not consistently meet endotoxin specification for devices that contact the cerebrospinal fluid. Elevated endotoxin levels may lead to neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea. | Environmental Monitoring |
| 2026-06-24 | Class II | Medline Industries, LPZ-2488-2026 | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. | Validation & Qualification |
| 2026-06-24 | Class II | Medline Industries, LPZ-2428-2026 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | Risk Management & CAPA |
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.