[ 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 |
|---|---|---|---|---|
| 2026-05-06 | Class II | Becton Dickinson & Co.Z-1983-2026 | BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification. | — |
| 2026-05-06 | Class II | Siemens Healthcare Diagnostics IncZ-2005-2026 | Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low pH or mTCO2 reading can lead to inappropriate treatment of nonexistent acidosis (respiratory of metabolic) or missed diagnosis of alkalosis (a true high pH: respiratory or metabolic alkalosis), potentially causing harm through unnecessary interventions with the former or failure to deliver appropriate treatment with the latter. | — |
| 2026-05-06 | Class II | Abbott Point Of Care Inc.Z-1999-2026 | Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems. | Risk Management & CAPA |
| 2026-05-06 | Class II | Medline Industries, LPZ-2018-2026 | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | Environmental Monitoring |
| 2026-05-06 | Class II | Medline Industries, LPZ-2020-2026 | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | Environmental Monitoring |
| 2026-05-06 | Class II | Philips North AmericaZ-1968-2026 | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | — |
| 2026-05-06 | Class II | Medtronic, Inc.Z-1948-2026 | Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D) implanted. The observation is caused by an interaction between the Sphere-9 catheter current flow and a safety feature built into Biotronik ICDs and CRT Ds. Medtronic recommends physicians use increased caution when using the Sphere-9 catheter for RF ablation therapy in patients implanted with a Biotronik ICD/CRT-D system, and to ensure external defibrillation systems are readily available. | — |
| 2026-05-06 | Class II | Medline Industries, LPZ-2045-2026 | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit. | Environmental Monitoring |
| 2026-05-06 | Class II | Medline Industries, LPZ-2030-2026 | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | Environmental Monitoring |
| 2026-05-06 | Class II | Philips North AmericaZ-1969-2026 | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | — |
| 2026-05-06 | Class II | Medline Industries, LPZ-2014-2026 | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | Environmental Monitoring |
| 2026-05-06 | Class II | Medline Industries, LPZ-2012-2026 | During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin. | Environmental Monitoring |
| 2026-05-06 | Class I | WHILL, INC.Z-1826-2026 | Cyber vulnerability of BLE communication was found by CISA VDP program. | — |
| 2026-05-06 | Class II | Medline Industries, LPZ-2040-2026 | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit. | Environmental Monitoring |
| 2026-05-06 | Class II | DEPUY (IRELAND)Z-1987-2026 | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Environmental Monitoring |
| 2026-05-06 | Class II | Merit Medical Systems, Inc.Z-2003-2026 | catheter may experience resistance when being advanced over the guidewire | — |
| 2026-05-06 | Class II | Healthmark Industries Co., Inc.Z-1943-2026 | Product does not have FDA clearance. | — |
| 2026-05-06 | Class II | Philips North AmericaZ-1964-2026 | The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small. | — |
| 2026-04-29 | Class II | LSL Healthcare Inc.Z-1932-2026 | Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility. | Environmental Monitoring |
| 2026-04-29 | Class II | Medline Industries, LPZ-1876-2026 | Unapproved design changes to the products outside of the 510(k) clearance. | Documentation & Change Control |
| 2026-04-29 | Class II | Angiodynamics, Inc.Z-1873-2026 | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | Risk Management & CAPA |
| 2026-04-29 | Class II | Angiodynamics, Inc.Z-1862-2026 | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | Risk Management & CAPA |
| 2026-04-29 | Class II | Angiodynamics, Inc.Z-1864-2026 | The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub. | Risk Management & CAPA |
| 2026-04-29 | Class II | Windstone Medical Packaging, Inc.Z-1921-2026 | The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion). | — |
| 2026-04-29 | Class II | Medline Industries, LPZ-1838-2026 | The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. | Documentation & Change Control |
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.