[ 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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3,493 matching recalls
DateClassFirmReasonQuality domain
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1169-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1167-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1165-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1168-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1173-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class IIAMY'S KITCHEN INC.H-1174-2026Potential for spoilage.—
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1161-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1170-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1163-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class IIW.Y. Industries, Inc.H-1157-2026Product may contain metal fragments.Environmental Monitoring
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1164-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class IIGeneral Mills James Ford Bell Technical CenterH-1154-2026Potential foreign material (glass)Environmental Monitoring
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1162-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class IIGE Medical Systems, LLCZ-2728-2026GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and collimator to drop downward on the column track. This could result in patient injury during an exam.—
2026-07-22Class IAbiomed, Inc.Z-2693-2026A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.Risk Management & CAPA
2026-07-22Class ID'Dioses Fruit Pops, Inc.H-1158-2026May contain undeclared milk, pecans, pistachios, yellow #5 and red #40.Documentation & Change Control
2026-07-22Class IIChocolate Bar Holdings LLCH-1156-2026Undeclared milk allergen.Documentation & Change Control
2026-07-22Class IIGeneral Mills James Ford Bell Technical CenterH-1155-2026Potential foreign material (glass)Environmental Monitoring
2026-07-22Class IIBoston Scientific CorporationZ-2725-2026Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from the system, potentially requiring device exchange and prolonging the procedure.—
2026-07-22Class IAbiomed, Inc.Z-2682-2026A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.Risk Management & CAPA
2026-07-22Class IIPapablic IncZ-2734-2026Potential for brush heads to break.—
2026-07-22Class IAbiomed, Inc.Z-2685-2026A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.Risk Management & CAPA
2026-07-22Class IIICU Medical, Inc.Z-2723-2026In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.—
2026-07-22Class IIDaavlin Distributing CompanyZ-2744-2026Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).Documentation & Change Control
2026-07-22Class IIChiesi USA, Inc.D-0689-2026Lack of Assurance of SterilityEnvironmental 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.