[ 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 I | AVID Medical, Inc.Z-1973-2026 | 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 | Katalyst Surgical, LLCZ-2069-2026 | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Risk Management & CAPA |
| 2026-05-13 | Class I | AVID Medical, Inc.Z-1976-2026 | 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 I | AVID Medical, Inc.Z-1975-2026 | 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 | Katalyst Surgical, LLCZ-2080-2026 | Ophthalmic Tissue Forceps (DEX") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled Ophthalmic soft-tissue surgical forceps, probe-like, single use . Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box. | Environmental Monitoring |
| 2026-05-13 | Class II | Medline Industries, LPZ-2089-2026 | 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 | Katalyst Surgical, LLCZ-2079-2026 | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Risk Management & CAPA |
| 2026-05-13 | Class II | Medline Industries, LPZ-2120-2026 | 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 | Katalyst Surgical, LLCZ-2078-2026 | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Risk Management & CAPA |
| 2026-05-13 | Class I | AVID Medical, Inc.Z-1978-2026 | 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 | DFI Co., Ltd.Z-2083-2026 | The devices were distributed without required FDA premarket clearance or approval. | Documentation & Change Control |
| 2026-05-13 | Class II | Medline Industries, LPZ-2124-2026 | 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 | Katalyst Surgical, LLCZ-2077-2026 | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Risk Management & CAPA |
| 2026-05-13 | Class II | Katalyst Surgical, LLCZ-2075-2026 | Field Safety Corrective Action for IFU in DEX Forceps and Scissors. | Risk Management & CAPA |
| 2026-05-13 | Class I | Medical Action Industries, Inc. 306Z-2007-2026 | Convenience kit contains a syringe in which the rotating adapter may unwind during use, resulting in a loose connection and/or full disconnection between the syringe and manifold" | — |
| 2026-05-13 | Class II | Medline Industries, LPZ-2102-2026 | 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-2130-2026 | 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-2125-2026 | 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-2112-2026 | 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-2122-2026 | 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-2121-2026 | 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-2097-2026 | 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 | AVID Medical, Inc.Z-1977-2026 | 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-2114-2026 | 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 | Erbe Medical, LLCZ-2063-2026 | 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 |
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.