[ 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 |
|---|---|---|---|---|
| 2026-06-03 | Class I | Medline Industries, LPZ-2233-2026 | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. | Environmental Monitoring |
| 2026-06-03 | Class II | Medline Industries, LPZ-2260-2026 | Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and blister pack are labeled as a 1 mL Luer Lock Tuberculin Syringe (Product Code 1180100777), but the syringes inside are U-100 insulin syringes. | Environmental Monitoring |
| 2026-06-03 | Class I | Medline Industries, LPZ-2232-2026 | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. | Environmental Monitoring |
| 2026-06-03 | Class II | Medtronic NeuromodulationZ-2240-2026 | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. | Documentation & Change Control |
| 2026-06-03 | Class II | GE Medical Systems Information Technologies IncZ-2247-2026 | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). | — |
| 2026-06-03 | Class I | Bolton Medical Inc.Z-2160-2026 | Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system. | Documentation & Change Control |
| 2026-06-03 | Class I | Medline Industries, LPZ-2236-2026 | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. | Environmental Monitoring |
| 2026-06-03 | Class II | GE Medical Systems Information Technologies IncZ-2246-2026 | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). | — |
| 2026-06-03 | Class I | Medline Industries, LPZ-2234-2026 | Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology testing data integrity concerns and reported efficacy complaints. | Environmental Monitoring |
| 2026-06-03 | Class I | Abiomed, Inc.Z-2238-2026 | Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console. | — |
| 2026-06-03 | Class II | Medtronic NeuromodulationZ-2241-2026 | A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates. | Documentation & Change Control |
| 2026-06-03 | Class II | GE Medical Systems Information Technologies IncZ-2245-2026 | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the CARESCAPE Central Station or CIC Pro Clinical Information Center (Central Station). | — |
| 2026-06-03 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2259-2026 | It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality. | — |
| 2026-06-03 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2258-2026 | It was identified that HDDs used in the PCs of Azurion and Allura systems may show a decrease in performance as they age, particularly beyond six years of service. Issues with an HDD may, depending on the specific system PC in which the affected HDD is installed, result in loss of imaging functionality. Additionally, in Allura systems, this may lead to loss of motorized movement, or loss of data. In some cases, a system restart may temporarily restore functionality. | — |
| 2026-06-03 | Class II | Devicor Medical Products IncZ-2239-2026 | Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers. | Documentation & Change Control |
| 2026-05-27 | Class II | Medtronic Perfusion SystemsZ-2218-2026 | Certain lots of product have the potential for a sterile barrier breach. | Environmental Monitoring |
| 2026-05-27 | Class II | Medtronic Perfusion SystemsZ-2219-2026 | Certain lots of product have the potential for a sterile barrier breach. | Environmental Monitoring |
| 2026-05-27 | Class II | ICU Medical, Inc.Z-2210-2026 | Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible. | — |
| 2026-05-27 | Class II | Medtronic Perfusion SystemsZ-2216-2026 | Certain lots of product have the potential for a sterile barrier breach. | Environmental Monitoring |
| 2026-05-27 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2228-2026 | The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system. | Validation & Qualification |
| 2026-05-27 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2229-2026 | The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system. | Validation & Qualification |
| 2026-05-27 | Class II | Medtronic Perfusion SystemsZ-2215-2026 | Certain lots of product have the potential for a sterile barrier breach. | Environmental Monitoring |
| 2026-05-27 | Class II | Medtronic Perfusion SystemsZ-2214-2026 | Certain lots of product have the potential for a sterile barrier breach. | Environmental Monitoring |
| 2026-05-27 | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Z-2225-2026 | Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module. | — |
| 2026-05-27 | Class II | Becton, Dickinson and CompanyZ-2204-2026 | Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss. | Risk Management & CAPA |
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.