[ 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
2026-04-08Class IICivco Medical Instruments Co. Inc.Z-1738-2026There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.Documentation & Change Control
2026-04-08Class IIThe Maros Group, LLCH-0644-2026Undeclared sulfites.Documentation & Change Control
2026-04-08Class IIIPocas International Corp.H-0633-2026Packaging integrity issue that may compromise product quality .Documentation & Change Control
2026-04-08Class IIIPocas International Corp.H-0636-2026Packaging integrity issue that may compromise product quality .Documentation & Change Control
2026-04-08Class IIIPocas International Corp.H-0635-2026Packaging integrity issue that may compromise product quality .Documentation & Change Control
2026-04-08Class IISynthes (USA) Products LLCZ-1702-2026A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.Documentation & Change Control
2026-04-08Class IIIPocas International Corp.H-0634-2026Packaging integrity issue that may compromise product quality .Documentation & Change Control
2026-04-08Class IIThe Maros Group, LLCH-0645-2026Undeclared milk.Documentation & Change Control
2026-04-08Class IICardinal Health 200, LLCZ-1768-2026The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.Documentation & Change Control
2026-04-08Class IISynthes (USA) Products LLCZ-1703-2026A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.Documentation & Change Control
2026-04-08Class IICivco Medical Instruments Co. Inc.Z-1734-2026There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.Documentation & Change Control
2026-04-01Class IIIPhilips Ultrasound, IncZ-1620-2026To provide clarification and labelling to define the useful life of ultrasound transducers in the field.Documentation & Change Control
2026-04-01Class IIIPhilips Ultrasound, IncZ-1619-2026To provide clarification and labelling to define the useful life of ultrasound transducers in the field.Documentation & Change Control
2026-04-01Class IIKoven Technology, Inc.Z-1631-2026Product labeling includes a fetal indication for use that is not cleared under its 510(k).Documentation & Change Control
2026-04-01Class IIIPhilips Ultrasound, IncZ-1628-2026To provide clarification and labelling to define the useful life of ultrasound transducers in the field.Documentation & Change Control
2026-04-01Class IIIPhilips Ultrasound, IncZ-1618-2026To provide clarification and labelling to define the useful life of ultrasound transducers in the field.Documentation & Change Control
2026-04-01Class IIStraumann USA LLCZ-1633-2026A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.Documentation & Change Control
2026-04-01Class IIIPhilips Ultrasound, IncZ-1624-2026To provide clarification and labelling to define the useful life of ultrasound transducers in the field.Documentation & Change Control
2026-04-01Class IIIPhilips Ultrasound, IncZ-1622-2026To provide clarification and labelling to define the useful life of ultrasound transducers in the field.Documentation & Change Control
2026-04-01Class IIHerbal Creations USAH-0602-2026Bulk packaged dietary ingredient manufacturer product label does not declare Milk as an allergen ingredient.Documentation & Change Control
2026-04-01Class IIStraumann USA LLCZ-1632-2026A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments. More specifically, a raw material bar of TAN-material (SAP #701924 / Lot 7130439) was incorrectly identified as a Titanium Bar Ti Gr4 D (SAP #701922 / Lot 7130430). As a result, RC Titanium abutments were manufactured using the TAN Bar material on Mill-from-Bar Machine 396-06.Documentation & Change Control
2026-04-01Class INuts.com Inc.H-0632-2026Undeclared Allergen - Wheat and Soy (from Soy Lecithin). The ingredient statement and allergen information do not include wheat or soy.Documentation & Change Control
2026-04-01Class IDistribuidora de Alimentos Sendero LLCH-0649-2026Gorditas and Doraditas are missing the following allergens in product label: Wheat and SoyDocumentation & Change Control
2026-04-01Class IITandem Diabetes Care, Inc.Z-1636-2026The Czech language user guide contained multiple translation errors. The most significant error was that it incorrectly instructs users to verify that the infusion set is connected to the body, when it should instead direct users to confirm that the infusion set is not connected to the body. Following this instruction could result in unintended insulin delivery, potentially leading to a hypoglycemic event.Documentation & Change Control
2026-04-01Class IDistribuidora de Alimentos Sendero LLCH-0648-2026Gorditas and Doraditas are missing the following allergens in product label: Wheat and SoyDocumentation & 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.