[ 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 |
|---|---|---|---|---|
| 2026-05-13 | Class II | Erbe Medical, LLCZ-2064-2026 | Devices 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 |
| 2026-05-13 | Class II | Katalyst Surgical, LLCZ-2072-2026 | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Risk Management & CAPA |
| 2026-05-13 | Class I | Cook IncorporatedZ-1934-2026 | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death. | Risk Management & CAPA |
| 2026-05-13 | Class II | Medline Industries, LPZ-2099-2026 | Medline 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 |
| 2026-05-13 | Class II | Medline Industries, LPZ-2123-2026 | Medline 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 |
| 2026-05-13 | Class I | Intuitive Surgical, Inc.Z-1855-2026 | Reloads for curved-tipped stapler may potentially produce an incomplete staple line. | — |
| 2026-05-13 | Class I | Cook IncorporatedZ-1935-2026 | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death. | Risk Management & CAPA |
| 2026-05-13 | Class II | Mint Medical GmbHZ-2068-2026 | If the connection between a mint Lesion workstation and the mint Lesion server is interrupted while performing a read, in rare cases some information may be lost or incorrectly linked to other patients. | Documentation & Change Control |
| 2026-05-13 | Class II | Medline Industries, LPZ-2106-2026 | Medline 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 |
| 2026-05-13 | Class II | BioFire Diagnostics, LLCZ-2081-2026 | Respiratory/sore throat panel test may result in false negative results and control failures. | — |
| 2026-05-13 | Class I | Cook IncorporatedZ-1936-2026 | Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death. | Risk Management & CAPA |
| 2026-05-13 | Class II | Katalyst Surgical, LLCZ-2076-2026 | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Risk Management & CAPA |
| 2026-05-13 | Class I | AVID Medical, Inc.Z-1972-2026 | Potential 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. | — |
| 2026-05-13 | Class II | Medline Industries, LPZ-2119-2026 | Medline 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 |
| 2026-05-13 | Class II | Medline Industries, LPZ-2104-2026 | Medline 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 |
| 2026-05-13 | Class II | DFI Co., Ltd.Z-2087-2026 | The devices were distributed without required FDA premarket clearance or approval. | Documentation & Change Control |
| 2026-05-13 | Class II | Medline Industries, LPZ-2100-2026 | Medline 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 |
| 2026-05-13 | Class II | Physio-Control, Inc.Z-2065-2026 | Some 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. | — |
| 2026-05-13 | Class II | Centinel Spine, Inc.Z-2050-2026 | Product 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 |
| 2026-05-13 | Class II | Medline Industries, LPZ-2092-2026 | Medline 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 |
| 2026-05-13 | Class II | Medline Industries, LPZ-2091-2026 | Medline 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 |
| 2026-05-13 | Class II | Medline Industries, LPZ-2108-2026 | Medline 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 |
| 2026-05-13 | Class I | American Contract Systems IncZ-1981-2026 | Impacted kits contain syringes recalled by Medline Industries. Syringe rotating adaptor may unwind during use, which may result in a loose connection or full disconnection between the syringe and manifold. Potential risk for biohazard exposure, blood loss, infection, or air embolism. | — |
| 2026-05-13 | Class II | Katalyst Surgical, LLCZ-2070-2026 | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Risk Management & CAPA |
| 2026-05-13 | Class I | Ventec Life Systems, Inc.Z-1942-2026 | Respiratory system intended to provide continuous/intermittent ventilator support, may not have been evaluated under all intended high-pressure conditions during production testing, so an oxygen leak condition could occur that may lead to reduced below intended levels of fraction of inspired oxygen delivery prior to and during ventilation and this oxygen-enriched environment may increase fire risk | — |
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.