[ 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
2026-07-15	Class II	Integra LifeSciences Corp. (NeuroSciences)Z-2714-2026	The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.	Environmental Monitoring
2026-07-15	Class II	Reliance Life Sciences Private LimitedD-0674-2026	Lack of Sterility Assurance	Environmental Monitoring
2026-07-15	Class I	Trafa Pharmaceutical Inc.H-1144-2026	Potential contamination with Salmonella	Environmental Monitoring
2026-07-15	Class II	Reliance Life Sciences Private LimitedD-0671-2026	Lack of Sterility Assurance	Environmental Monitoring
2026-07-15	Class I	Fresh & Ready Foods LLCH-1149-2026	Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Fillet sandwich. Raw breaded chicken patties pose a risk of foodborne illness due to the potential presence of Salmonella.	Environmental Monitoring
2026-07-15	Class II	Reliance Life Sciences Private LimitedD-0673-2026	Lack of Sterility Assurance	Environmental Monitoring
2026-07-15	Class I	Fresh & Ready Foods LLCH-1148-2026	Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Deluxe With Bacon sandwich. Raw breaded chicken patties pose a risk of foodborne illness due to the potential presence of Salmonella.	Environmental Monitoring
2026-07-08	Class II	Blaine Labs IncD-0699-2026	CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated	Environmental Monitoring
2026-07-08	Class II	CareFusion 213, LLCD-0651-2026	Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel	Environmental Monitoring
2026-07-08	Class II	Asclemed USA Inc.D-0659-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-07-08	Class I	Blaine Labs IncD-0692-2026	Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp	Environmental Monitoring
2026-07-08	Class II	ACCORD BIOPHARMA INCD-0653-2026	Lack of assurance of Sterility:	Environmental Monitoring
2026-07-08	Class II	CareFusion 213, LLCD-0644-2026	Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel	Environmental Monitoring
2026-07-08	Class II	CareFusion 213, LLCD-0652-2026	Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel	Environmental Monitoring
2026-07-08	Class II	CareFusion 213, LLCD-0647-2026	Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel	Environmental Monitoring
2026-07-08	Class II	MARS SNACKINGH-1130-2026	Potential contamination with plastic material	Environmental Monitoring
2026-07-08	Class II	CareFusion 213, LLCD-0645-2026	Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel	Environmental Monitoring
2026-07-08	Class II	Asclemed USA Inc.D-0658-2026	Lack of Assurance of Sterility	Environmental Monitoring
2026-07-08	Class II	CareFusion 213, LLCD-0643-2026	Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel	Environmental Monitoring
2026-07-08	Class II	Wells Enterprises, Inc.H-1151-2026	Elevated coliforms	Environmental Monitoring
2026-07-08	Class I	NARA ORGANICS INCH-1137-2026	Product may be contaminated with Clostridium botulinum.	Environmental Monitoring
2026-07-08	Class II	CareFusion 213, LLCD-0649-2026	Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel	Environmental Monitoring
2026-07-08	Class II	Blaine Labs IncD-0693-2026	CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated	Environmental Monitoring
2026-07-08	Class II	MARS SNACKINGH-1129-2026	Potential contamination with plastic material	Environmental Monitoring
2026-07-08	Class II	CareFusion 213, LLCD-0646-2026	Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel	Environmental Monitoring

Page 2 of 50

← Prev Next →

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.