[ 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.
3,493 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 2026-06-24 | Class II | Medline Industries, LPZ-2494-2026 | 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-2498-2026 | 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 | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2411-2026 | Philips Allura Xper and MultiDiagnost-Eleva systems Hand switch button not fully releasing potentially leading to loss of imaging functionality or unintended radiation exposure and additional contrast injection | — |
| 2026-06-24 | Class I | Datex-Ohmeda IncZ-2359-2026 | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient. | — |
| 2026-06-24 | Class II | Medline Industries, LPZ-2425-2026 | 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-2389-2026 | 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-2374-2026 | 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-2375-2026 | 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-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 I | ARROW INTERNATIONAL, LLCZ-2369-2026 | 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-2500-2026 | 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-2497-2026 | 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-2384-2026 | 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-2424-2026 | 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-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 | Beta Bionics, Inc.Z-2513-2026 | The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the Lock Screen, no screen transition occurs, and the user remains on the Lock Screen. Because the user cannot exit the Lock Screen, the user is unable to perform a cartridge change or meal announcement. If this occurs and therapy is in progress, therapy will continue normally until the insulin cartridge is depleted. The user will be unable to perform a cartridge change or a meal announcement and will be stuck on the screen until the battery fully drains. This can lead to hyperglycemia. | Data Integrity |
| 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 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 | ARROW INTERNATIONAL, LLCZ-2387-2026 | 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-2382-2026 | 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 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 II | Howmedica Osteonics Corp.Z-2462-2026 | 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-2421-2026 | 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 | Keystone IndustriesD-0605-2026 | Defective container:may contain bottles with incomplete seals | — |
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.