[ 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.

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1,235 matching recalls
DateClassFirmReasonQuality domain
2026-06-17Class IIAVID Medical, Inc.Z-2408-2026Inadvertent distribution of sealed pouches that had not undergone validated sterilization.Environmental Monitoring
2026-06-17Class IIBoston Scientific CorporationZ-2413-2026Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.Environmental Monitoring
2026-06-10Class IThe Coffee Connexion Co., IncH-0908-2026Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contaminationEnvironmental Monitoring
2026-06-10Class IIStraus Family CreameryH-0897-2026Potential contamination with foreign objects (metal pieces).Environmental Monitoring
2026-06-10Class IIStraus Family CreameryH-0895-2026Potential contamination with foreign objects (metal pieces).Environmental Monitoring
2026-06-10Class IISpectra Medical Devices, LlcD-0554-2026Lack of Assurance of SterilityEnvironmental Monitoring
2026-06-10Class IThe Coffee Connexion Co., IncH-0907-2026Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contaminationEnvironmental Monitoring
2026-06-10Class IJCB Flavors, LLCH-0890-2026Products may be potentially contaminated with Salmonella.Environmental Monitoring
2026-06-10Class IThe Coffee Connexion Co., IncH-0910-2026Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contaminationEnvironmental Monitoring
2026-06-10Class IIUniversity of California Health Milk BankH-0948-2026Product is potentially contaminated with foreign material (plastic particles).Environmental Monitoring
2026-06-10Class IJCB Flavors, LLCH-0886-2026Products may be potentially contaminated with Salmonella.Environmental Monitoring
2026-06-10Class IThe a2 Milk CompanyH-0891-2026Possible contamination with Cereulide toxin.Environmental Monitoring
2026-06-10Class IIQ PRODUCE, LLCH-0898-2026Imported Enoki Mushrooms samples collected by Florida Department of Health tested positive for Listeria Monocytogenes.Environmental Monitoring
2026-06-10Class IJCB Flavors, LLCH-0882-2026Products may be potentially contaminated with Salmonella.Environmental Monitoring
2026-06-10Class IIStraus Family CreameryH-0896-2026Potential contamination with foreign objects (metal pieces).Environmental Monitoring
2026-06-10Class IGuittard Chocolate CompanyH-0861-2026Potential contamination with SalmonellaEnvironmental Monitoring
2026-06-10Class IJCB Flavors, LLCH-0887-2026Products may be potentially contaminated with Salmonella.Environmental Monitoring
2026-06-10Class IJCB Flavors, LLCH-0881-2026Products may be potentially contaminated with Salmonella.Environmental Monitoring
2026-06-10Class ITerra Medi LLCH-0899-2026Un-eviscerated fish may be contaminated with clostridium botulinumEnvironmental Monitoring
2026-06-10Class IIStraus Family CreameryH-0894-2026Potential contamination with foreign objects (metal pieces).Environmental Monitoring
2026-06-10Class IThe Coffee Connexion Co., IncH-0909-2026Product contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contaminationEnvironmental Monitoring
2026-06-10Class IJCB Flavors, LLCH-0889-2026Products may be potentially contaminated with Salmonella.Environmental Monitoring
2026-06-10Class ISKS Copackfood-20260610-SKS CopackProducts may potentially be contaminated with Salmonella.Environmental Monitoring
2026-06-10Class IJCB Flavors, LLCH-0883-2026Products may be potentially contaminated with Salmonella.Environmental Monitoring
2026-06-10Class INassar Investment Company LLCH-0860-2026Salmonella. The firm was notified by the North Carolina Department of Agriculture that the product test positive for Salmonella.Environmental Monitoring
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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.