[ 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
214
Class I (most serious)
167
Drug
520
Device
313
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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3,465 matching recalls
DateClassFirmReasonQuality domain
2026-05-06Class IIMedline Industries, LPZ-2019-2026During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.Environmental Monitoring
2026-05-06Class IIDEPUY (IRELAND)Z-1985-2026The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.Environmental Monitoring
2026-05-06Class IIAbbott Point Of Care Inc.Z-2000-2026Approximately 7.6% of cartridges from specific i-STAT EG7+ (list number 03P76-25), i-STAT EG6+ (list number 03P77-25) and i-STAT G3+ (list number 03P78-26) cartridge lots in the U.S. marketplace may report higher than expected PCO2 and lower than expected pH results due to a manufacturing issue. A falsely high pCO2 together with a falsely low pH makes the blood gas appear as if the patient is in severe respiratory acidosis. If the clinician believes the values are real, it may trigger unnecessary or even harmful interventions such as unnecessary ventilator changes, unnecessary medications, potential harm from overcorrection, or delays in identifying true problems.Risk Management & CAPA
2026-05-06Class IIPhilips North AmericaZ-1962-2026The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.—
2026-05-06Class IIMedline Industries, LPZ-2028-2026During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.Environmental Monitoring
2026-05-06Class IIClinical Innovations, LLCZ-1945-2026Due to complaints of device breakage at the traction force gauge to handle joint.Risk Management & CAPA
2026-05-06Class IIZimmer, Inc.Z-1946-2026Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to clinically insignificant extension of surgery or infection leading to surgical intervention.Environmental Monitoring
2026-05-06Class IIMedline Industries, LPZ-2025-2026During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.Environmental Monitoring
2026-05-06Class IIMedline Industries, LPZ-2036-2026During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.Environmental Monitoring
2026-05-06Class IIPhilips North AmericaZ-1967-2026The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.—
2026-05-06Class IIDEPUY (IRELAND)Z-1990-2026The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.Environmental Monitoring
2026-05-06Class IIPhilips North AmericaZ-1965-2026The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.—
2026-05-06Class IIMedline Industries, LPZ-2034-2026During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.Environmental Monitoring
2026-05-06Class IIMedline Industries, LPZ-2024-2026During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.Environmental Monitoring
2026-05-06Class IIGuangdong Zonegoing Food Co., LTDH-0678-2026Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).Documentation & Change Control
2026-05-06Class IILACTALIS CANADA, INCH-0680-2026Product may contain foreign objects, specifically glass.Environmental Monitoring
2026-05-06Class IISchreiber Foods IncH-0675-2026Undeclared allergen (almond).Documentation & Change Control
2026-05-06Class IIGuangdong Zonegoing Food Co., LTDH-0676-2026Products contain unapproved colors, specifically tartrazine (FD&C Yellow 5), sunset yellow (FD&C Yellow 6), and allura red (FD&C Red 40).Documentation & Change Control
2026-05-06Class IIThe Mochi Ice Cream Company, LLCH-0684-2026Foreign object found inside retail container.Environmental Monitoring
2026-05-06Class IIKing Juice Company, Inc.H-0685-2026Product contains undeclared Yellow No. 5.Documentation & Change Control
2026-05-06Class IIGanesha Enterprises LLCH-0683-2026Undeclared food colorings (Yellow 6, Blue 1, and Yellow 5) and unapproved Acid Red 14.Documentation & Change Control
2026-05-06Class IHEMU TRADING INCH-0686-2026product tested positive for Listeria Monocytogenes.Environmental Monitoring
2026-04-29Class IIThe Harvard Drug Group LLCD-0493-2026Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.Validation & Qualification
2026-04-29Class IIHarrow Eye LLCD-0489-2026Lack of Assurance of SterilityEnvironmental Monitoring
2026-04-29Class IIB BRAUN MEDICAL INCD-0495-2026Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.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.