[ 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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758 matching recalls
DateClassFirmReasonQuality domain
2026-04-29Class IIMedline Industries, LPZ-1887-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1836-2026The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1839-2026The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1847-2026The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1886-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1892-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1885-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1883-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIARROW INTERNATIONAL, LLCZ-1916-2026Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufacturedDocumentation & Change Control
2026-04-29Class IIARROW INTERNATIONAL, LLCZ-1913-2026Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufacturedDocumentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1882-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIDiversatek HealthcareZ-1940-2026The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.Documentation & Change Control
2026-04-29Class IIDiversatek HealthcareZ-1938-2026The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.Documentation & Change Control
2026-04-29Class IIMarquez Brothers International, Inc.H-0674-2026Undeclared milk.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1878-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1884-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1880-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1876-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIARROW INTERNATIONAL, LLCZ-1912-2026Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufacturedDocumentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1850-2026The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.Documentation & Change Control
2026-04-29Class IIARROW INTERNATIONAL, LLCZ-1917-2026Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufacturedDocumentation & Change Control
2026-04-29Class IIMarquez Brothers International, Inc.H-0672-2026Undeclared milk.Documentation & Change Control
2026-04-29Class IIMarquez Brothers International, Inc.H-0673-2026Undeclared milk.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1891-2026Unapproved design changes to the products outside of the 510(k) clearance.Documentation & Change Control
2026-04-29Class IIMedline Industries, LPZ-1844-2026The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.Documentation & Change Control
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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.