[ 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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3,465 matching recalls
DateClassFirmReasonQuality domain
2026-05-13Class IISilver Moon LP dba Loard's Ice CreamH-0720-2026Undeclared Milk, Red #40, Blue #1, Blue #2.Documentation & Change Control
2026-05-13Class IIWalker Honey CoH-0702-2026Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.—
2026-05-13Class IIPost Consumer Brands, LLCH-0776-2026Foreign Material (plastic)Environmental Monitoring
2026-05-13Class IIITops Markets LLCH-0688-2026The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firmEnvironmental Monitoring
2026-05-13Class IISilver Moon LP dba Loard's Ice CreamH-0718-2026Undeclared Milk, Red #40, Blue #1.Documentation & Change Control
2026-05-13Class IIGreen Organic VegetablesH-0694-2026Foreign object: metal piecesEnvironmental Monitoring
2026-05-13Class IIWalker Honey CoH-0705-2026Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.—
2026-05-13Class IIMedline Industries, LPZ-2091-2026Medline 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 IISilver Moon LP dba Loard's Ice CreamH-0756-2026Undeclared Yellow #5Documentation & Change Control
2026-05-13Class IISilver Moon LP dba Loard's Ice CreamH-0722-2026Undeclared Milk.Documentation & Change Control
2026-05-13Class IIMedline Industries, LPZ-2099-2026Medline 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 IIIFalcon Trading Co., Inc.H-0697-2026Potential contamination with pesticides, haloxyfop and thiamethoxamEnvironmental Monitoring
2026-05-13Class IAVID Medical, Inc.Z-1972-2026Potential 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 IIMedline Industries, LPZ-2119-2026Medline 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-2104-2026Medline 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-2087-2026The devices were distributed without required FDA premarket clearance or approval.Documentation & Change Control
2026-05-13Class IIMedline Industries, LPZ-2100-2026Medline 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 IIPhysio-Control, Inc.Z-2065-2026Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.—
2026-05-13Class IICentinel Spine, Inc.Z-2050-2026Product labeling mix up. The prodisc C SK U.S. Implant Extra Large 6mm product was labeled as a 5mm and prodisc C SK U.S. Implant Extra Large 5mm product was labeled as a 6mm.Documentation & Change Control
2026-05-13Class IIMedline Industries, LPZ-2093-2026Medline 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-2116-2026Medline 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-2090-2026Medline 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-2096-2026Medline 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 IISpacelabs Healthcare, Inc.Z-2052-2026Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).Risk Management & CAPA
2026-05-13Class IIMedline Industries, LPZ-2095-2026Medline 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.