[ 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 | 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 | Milestone S.R.L.Z-1944-2026 | There is a possibility of reagent leakage from the specimen container. | — |
| 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 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 | 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 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-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 | DEPUY (IRELAND)Z-1989-2026 | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Environmental Monitoring |
| 2026-05-06 | Class II | Medline Industries, LPZ-2031-2026 | 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 | Merit Medical Systems, Inc.Z-2002-2026 | catheter may experience resistance when being advanced over the guidewire | — |
| 2026-05-06 | Class II | Philips North AmericaZ-1953-2026 | 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-2044-2026 | 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-2015-2026 | 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 | DEPUY (IRELAND)Z-1992-2026 | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Environmental Monitoring |
| 2026-05-06 | Class II | Medline Industries, LPZ-2010-2026 | 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-2019-2026 | 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 | DEPUY (IRELAND)Z-1985-2026 | The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility. | Environmental Monitoring |
| 2026-05-06 | Class II | Abbott Point Of Care Inc.Z-2000-2026 | 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 | Philips North AmericaZ-1962-2026 | 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-2028-2026 | 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 | Clinical Innovations, LLCZ-1945-2026 | Due to complaints of device breakage at the traction force gauge to handle joint. | Risk Management & CAPA |
| 2026-05-06 | Class II | Zimmer, Inc.Z-1946-2026 | Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention. | Environmental Monitoring |
| 2026-05-06 | Class II | Medline Industries, LPZ-2025-2026 | 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-2017-2026 | 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-2036-2026 | 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 |
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.