[ 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.

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1,158 matching recalls
DateClassFirmReasonQuality domain
2026-06-24Class IIMedline Industries, LPZ-2420-2026Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.Risk Management & CAPA
2026-06-24Class IIConMed CorporationZ-2466-2026Potential for overpressure alerts.—
2026-06-24Class IARROW INTERNATIONAL, LLCZ-2386-2026Lidocaine, 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
2026-06-24Class IIThoratec LLCZ-2518-2026Due to 11 volt Backup Battery failures.—
2026-06-24Class IIThoratec LLCZ-2519-2026Due to 11 volt Backup Battery failures.—
2026-06-24Class IARROW INTERNATIONAL, LLCZ-2385-2026Lidocaine, 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
2026-06-24Class IIMedline Industries, LPZ-2436-2026Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.Risk Management & CAPA
2026-06-24Class IIConMed CorporationZ-2471-2026Potential for overpressure alerts.—
2026-06-24Class IISteris CorporationZ-2449-2026The the plus and minus buttons (+/-) used to control light intensity on the light heads may detach.—
2026-06-24Class IARROW INTERNATIONAL, LLCZ-2371-2026Lidocaine, 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
2026-06-24Class IAbiomed, Inc.Z-2457-2026Exposure 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.—
2026-06-24Class IIMedline Industries, LPZ-2486-2026During 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
2026-06-24Class IIHowmedica Osteonics Corp.Z-2461-2026Stryker 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
2026-06-24Class IARROW INTERNATIONAL, LLCZ-2377-2026Lidocaine, 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
2026-06-24Class IIMedline Industries, LPZ-2438-2026Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.Risk Management & CAPA
2026-06-24Class IIMedline Industries, LPZ-2427-2026Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.Risk Management & CAPA
2026-06-24Class IIMedtronic Navigation, Inc.-BoxboroughZ-2451-2026Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware.Data Integrity
2026-06-24Class IIMedline Industries, LPZ-2434-2026Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.Risk Management & CAPA
2026-06-24Class IIConMed CorporationZ-2468-2026Potential for overpressure alerts.—
2026-06-24Class IARROW INTERNATIONAL, LLCZ-2397-2026Lidocaine, 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
2026-06-24Class IIMedline Industries, LPZ-2503-2026During 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
2026-06-24Class IIInspire Medical Systems Inc.Z-2516-2026Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.Validation & Qualification
2026-06-24Class IARROW INTERNATIONAL, LLCZ-2393-2026Lidocaine, 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
2026-06-24Class IIMedline Industries, LPZ-2479-2026During 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
2026-06-24Class IIStaar Surgical AGZ-2509-2026Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.—
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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.