[ 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
2026-07-08Class IIAsclemed USA Inc.D-0658-2026Lack of Assurance of SterilityEnvironmental Monitoring
2026-07-08Class IIAsclemed USA Inc.D-0659-2026Lack of Assurance of SterilityEnvironmental Monitoring
2026-07-08Class IIDEPUY (IRELAND)Z-2616-2026The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.Environmental Monitoring
2026-07-08Class IICareFusion 213, LLCD-0647-2026Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channelEnvironmental Monitoring
2026-07-08Class IICareFusion 213, LLCD-0643-2026Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channelEnvironmental Monitoring
2026-07-08Class IIDEPUY (IRELAND)Z-2617-2026The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.Environmental Monitoring
2026-07-08Class IICareFusion 213, LLCD-0649-2026Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channelEnvironmental Monitoring
2026-07-08Class IICareFusion 213, LLCD-0648-2026Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channelEnvironmental Monitoring
2026-07-08Class IIBlaine Labs IncD-0699-2026CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminatedEnvironmental Monitoring
2026-07-08Class INARA ORGANICS INCH-1137-2026Product may be contaminated with Clostridium botulinum.Environmental Monitoring
2026-07-08Class IWindstone Medical Packaging, Inc.Z-2620-2026Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.Environmental Monitoring
2026-07-08Class IICareFusion 213, LLCD-0645-2026Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channelEnvironmental Monitoring
2026-07-08Class IIBoston Scientific CorporationZ-2627-2026Potential sterile breach of the pouches in which devices are packaged.Environmental Monitoring
2026-07-08Class IIBlaine Labs IncD-0693-2026CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminatedEnvironmental Monitoring
2026-07-08Class IIBoston Scientific CorporationZ-2636-2026Potential sterile breach of the pouches in which devices are packaged.Environmental Monitoring
2026-07-08Class IICareFusion 213, LLCD-0646-2026Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channelEnvironmental Monitoring
2026-07-08Class IIMARS SNACKINGH-1129-2026Potential contamination with plastic materialEnvironmental Monitoring
2026-07-08Class IIBoston Scientific CorporationZ-2626-2026Potential sterile breach of the pouches in which devices are packaged.Environmental Monitoring
2026-07-08Class IWindstone Medical Packaging, Inc.Z-2622-2026Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.Environmental Monitoring
2026-07-08Class IIBoston Scientific CorporationZ-2628-2026Potential sterile breach of the pouches in which devices are packaged.Environmental Monitoring
2026-07-08Class IICareFusion 213, LLCD-0650-2026Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channelEnvironmental Monitoring
2026-07-08Class IITELEFLEX LLCZ-2639-2026Due to out-of-specification, or potential out-of-specification, levels of endotoxinsEnvironmental Monitoring
2026-07-08Class IIBoston Scientific CorporationZ-2630-2026Potential sterile breach of the pouches in which devices are packaged.Environmental Monitoring
2026-07-08Class IIZimmer Surgical IncZ-2674-2026Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.Environmental Monitoring
2026-07-08Class IMedline Industries, LPZ-2615-2026Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection. If particulate were to dislodge during use and contact circulating blood or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.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.