[ 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
214
Class I (most serious)
167
Drug
520
Device
313
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.
3,465 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 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 | Becton Dickinson & Co.Z-1982-2026 | 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 | Medline Industries, LPZ-2008-2026 | 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-2037-2026 | 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 | Hologic, IncZ-1949-2026 | It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling Barco Application Appearance Manager (AAM), altering calibration and compliance parameters, and adjusting additional display-related settings. This field correction is being conducted to restore affected system to the validated configuration and reinforce proper use in accordance with the Operator's Manual. | — |
| 2026-05-06 | Class II | Philips North AmericaZ-1966-2026 | 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 I | Boston Scientific CorporationZ-1771-2026 | Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia | — |
| 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 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-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 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-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 | 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 | 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 | 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 | Medline Industries, LPZ-2035-2026 | 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-2041-2026 | 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-2033-2026 | 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 III | Heraeus Medical GmbH (Dental Division)Z-1997-2026 | Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months). | Validation & Qualification |
| 2026-05-06 | Class II | DEPUY (IRELAND)Z-1988-2026 | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Environmental Monitoring |
| 2026-05-06 | Class II | Milestone S.R.L.Z-1944-2026 | There is a possibility of reagent leakage from the specimen container. | — |
| 2026-05-06 | Class II | Medline Industries, LPZ-2023-2026 | 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-2039-2026 | 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-1986-2026 | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Environmental Monitoring |
| 2026-05-06 | Class II | DEPUY (IRELAND)Z-1991-2026 | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | 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.