[ 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
2026-05-20Class IIIntegra LifeSciences Corp. (NeuroSciences)Z-2173-2026Out-of-specification endotoxin result that did not meet the acceptance criteria.Environmental Monitoring
2026-05-20Class IIGE Medical Systems, LLCZ-2152-2026GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.Data Integrity
2026-05-20Class IIHologic, IncZ-2168-2026Complaints have been received of systems developing loose, missing, or broken internal bolts over time.—
2026-05-20Class IIDJO, LLCZ-2135-2026Due to broken connector which may result in a temporary interruption of prescribed cold therapy.—
2026-05-20Class IMedline Industries, LPZ-2139-2026Medline has identified the presence of particulate within the fluid path of the Manifolds.Environmental Monitoring
2026-05-13Class IIErbe Medical, LLCZ-2062-2026Devices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more susceptible to unintended water flow from distal tip under unsupported third-party connector use conditions, which may lead to water aspiration, which may progress to aspiration pneumonia, acute respiratory distress syndrome, or respiratory failure.Environmental Monitoring
2026-05-13Class IAVID Medical, Inc.Z-1974-2026Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.—
2026-05-13Class IIKatalyst Surgical, LLCZ-2071-2026Field Safety Corrective Action for IFU in DEX Forceps and Scissors.Risk Management & CAPA
2026-05-13Class IIOrthorebirth Co LtdZ-2132-2026Resorbable bone void filler falls outside standard specifications.—
2026-05-13Class IIKatalyst Surgical, LLCZ-2074-2026Field Safety Corrective Action for IFU in DEX Forceps and Scissors.Risk Management & CAPA
2026-05-13Class IIDFI Co., Ltd.Z-2085-2026The devices were distributed without required FDA premarket clearance or approval.Documentation & Change Control
2026-05-13Class IAVID Medical, Inc.Z-1970-2026Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.—
2026-05-13Class IIDFI Co., Ltd.Z-2088-2026The devices were distributed without required FDA premarket clearance or approval.Documentation & Change Control
2026-05-13Class IIMedline Industries, LPZ-2113-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2107-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIDFI Co., Ltd.Z-2084-2026The devices were distributed without required FDA premarket clearance or approval.Documentation & Change Control
2026-05-13Class IIMedline Industries, LPZ-2105-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIOrthorebirth Co LtdZ-2131-2026Resorbable bone void filler falls outside standard specifications.—
2026-05-13Class IIMedline Industries, LPZ-2110-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2129-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIIntuitive Surgical, Inc.Z-2046-2026Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.—
2026-05-13Class IIMedline Industries, LPZ-2126-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIMedline Industries, LPZ-2118-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
2026-05-13Class IIDFI Co., Ltd.Z-2082-2026The devices were distributed without required FDA premarket clearance or approval.Documentation & Change Control
2026-05-13Class IIMedline Industries, LPZ-2103-2026Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.Environmental Monitoring
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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.