[ 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.
1,235 matching recalls
| Date | Class | Firm | Reason | Quality domain |
|---|---|---|---|---|
| 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 |
| 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 | Medline Industries, LPZ-2022-2026 | 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-2011-2026 | 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-1993-2026 | 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-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-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-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 | DEPUY (IRELAND)Z-1990-2026 | 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-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 | 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 | Thea Pharma, Inc.D-0500-2026 | Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. | 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 II | Thea Pharma, Inc.D-0501-2026 | Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer. | Environmental Monitoring |
| 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 | 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 I | HEMU TRADING INCH-0686-2026 | product tested positive for Listeria Monocytogenes. | 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 | 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 | LACTALIS CANADA, INCH-0680-2026 | Product may contain foreign objects, specifically glass. | Environmental Monitoring |
| 2026-05-06 | Class II | The Mochi Ice Cream Company, LLCH-0684-2026 | Foreign object found inside retail container. | 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 |
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.