[ 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 |
|---|---|---|---|---|
| 2026-06-24 | Class I | ARROW INTERNATIONAL, LLCZ-2364-2026 | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. | Environmental Monitoring |
| 2026-06-24 | Class I | ARROW INTERNATIONAL, LLCZ-2394-2026 | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. | Environmental Monitoring |
| 2026-06-24 | Class II | Medline Industries, LPZ-2493-2026 | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. | Validation & Qualification |
| 2026-06-24 | Class I | ARROW INTERNATIONAL, LLCZ-2381-2026 | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. | Environmental Monitoring |
| 2026-06-24 | Class I | Datex-Ohmeda IncZ-2357-2026 | Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in hypoxia or hyperoxia in the patient. | — |
| 2026-06-24 | Class I | ARROW INTERNATIONAL, LLCZ-2368-2026 | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries. | Environmental Monitoring |
| 2026-06-24 | Class II | Medline Industries, LPZ-2480-2026 | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification. | Validation & Qualification |
| 2026-06-24 | Class II | ConMed CorporationZ-2466-2026 | Potential for overpressure alerts. | — |
| 2026-06-24 | Class II | Medline Industries, LPZ-2420-2026 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | Risk Management & CAPA |
| 2026-06-24 | Class II | Medtronic Navigation, Inc.-BoxboroughZ-2451-2026 | Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware. | Data Integrity |
| 2026-06-24 | Class II | BD SWITZERLAND SARLZ-2514-2026 | Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable. | — |
| 2026-06-24 | Class II | ConMed CorporationZ-2469-2026 | Potential for overpressure alerts. | — |
| 2026-06-24 | Class II | Medline Industries, LPZ-2421-2026 | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | Risk Management & CAPA |
| 2026-06-17 | Class II | Avanos Medical, Inc.Z-2337-2026 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Environmental Monitoring |
| 2026-06-17 | Class II | INSPIREMD IncZ-2326-2026 | Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. | — |
| 2026-06-17 | Class II | Avanos Medical, Inc.Z-2348-2026 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Environmental Monitoring |
| 2026-06-17 | Class II | Micromed S.p.A.Z-2353-2026 | Natus has become aware of two complaints related to the SD LTM 64 PLUS where the EEG traces acquired from two or four different amplifiers used in a multiple amplifier configuration (128 or 256 channels) running firmware version 2022.02 were displayed with a shift of 1 second between the 64channels blocks. In rare circumstances, a fixed 1-second temporal delay may appear between two 64-channel modules with firmware 2021.02, 2022.01 or 2022.02 in a multi-module SEEG configuration, potentially leading to misinterpretation of results. | Data Integrity |
| 2026-06-17 | Class II | Avanos Medical, Inc.Z-2343-2026 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Environmental Monitoring |
| 2026-06-17 | Class II | Avanos Medical, Inc.Z-2346-2026 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Environmental Monitoring |
| 2026-06-17 | Class II | Avanos Medical, Inc.Z-2351-2026 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Environmental Monitoring |
| 2026-06-17 | Class II | Avanos Medical, Inc.Z-2338-2026 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Environmental Monitoring |
| 2026-06-17 | Class II | Avanos Medical, Inc.Z-2334-2026 | Lidocaine hydrochloride injection, the subject of a supplier recall for quality issues, were included into sterile kits and sets. | Environmental Monitoring |
| 2026-06-17 | Class II | In2bones USA, LLCZ-2355-2026 | Due to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label. | Documentation & Change Control |
| 2026-06-17 | Class II | GE Medical Systems, LLCZ-2314-2026 | GE HealthCare has become aware of a potential issue affecting an electrical cable on certain IGS systems equipped with Gaia generators. This issue could lead to a risk of electrical shock to service personnel performing installation, maintenance, or troubleshooting activities inside the C-FRT cabinet while power is ON. | — |
| 2026-06-17 | Class II | INSPIREMD IncZ-2325-2026 | Stent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. | — |
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.