[ 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.

409 matching recalls

Date	Class	Firm	Reason	Quality domain
2026-05-13	Class II	Katalyst Surgical, LLCZ-2079-2026	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.	Risk Management & CAPA
2026-05-13	Class II	Katalyst Surgical, LLCZ-2078-2026	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.	Risk Management & CAPA
2026-05-13	Class II	Katalyst Surgical, LLCZ-2077-2026	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.	Risk Management & CAPA
2026-05-13	Class II	Katalyst Surgical, LLCZ-2075-2026	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.	Risk Management & CAPA
2026-05-13	Class II	Katalyst Surgical, LLCZ-2073-2026	Field Safety Corrective Action for IFU in DEX Forceps and Scissors.	Risk Management & CAPA
2026-05-13	Class I	Cook IncorporatedZ-1934-2026	Marker bands may be at an increased risk of cracking/breakage. Potential adverse events that may result include increased procedural time, harms associated with device fragmentation/separation, and vessel injury. In a worst-case scenario, device fragmentation and separation may cause life-threatening harm or death.	Risk Management & CAPA
2026-05-06	Class II	Abbott Point Of Care Inc.Z-2000-2026	Approximately 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
2026-05-06	Class II	Clinical Innovations, LLCZ-1945-2026	Due to complaints of device breakage at the traction force gauge to handle joint.	Risk Management & CAPA
2026-05-06	Class II	Abbott Point Of Care Inc.Z-2001-2026	Approximately 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
2026-05-06	Class II	Advanced Bionics, LLCZ-1950-2026	The non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to replace the button/coin cell battery.	Risk Management & CAPA
2026-05-06	Class II	Abbott Point Of Care Inc.Z-1999-2026	Approximately 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
2026-05-06	Class II	Wells Pharma of Houston LLCD-0508-2026	cGMP deviations.	Risk Management & CAPA
2026-05-06	Class II	Wells Pharma of Houston LLCD-0502-2026	cGMP deviations.	Risk Management & CAPA
2026-05-06	Class II	Wells Pharma of Houston LLCD-0505-2026	cGMP deviations.	Risk Management & CAPA
2026-05-06	Class II	Wells Pharma of Houston LLCD-0503-2026	cGMP deviations.	Risk Management & CAPA
2026-05-06	Class II	Wells Pharma of Houston LLCD-0504-2026	cGMP deviations.	Risk Management & CAPA
2026-05-06	Class II	Wells Pharma of Houston LLCD-0506-2026	cGMP deviations.	Risk Management & CAPA
2026-05-06	Class II	Wells Pharma of Houston LLCD-0507-2026	cGMP deviations.	Risk Management & CAPA
2026-04-29	Class II	Angiodynamics, Inc.Z-1863-2026	The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.	Risk Management & CAPA
2026-04-29	Class II	Angiodynamics, Inc.Z-1862-2026	The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.	Risk Management & CAPA
2026-04-29	Class II	Angiodynamics, Inc.Z-1864-2026	The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.	Risk Management & CAPA
2026-04-29	Class II	Angiodynamics, Inc.Z-1866-2026	The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.	Risk Management & CAPA
2026-04-29	Class II	Angiodynamics, Inc.Z-1873-2026	The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.	Risk Management & CAPA
2026-04-29	Class II	Leading Pharma, LLCD-0486-2026	CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.	Risk Management & CAPA
2026-04-29	Class II	Angiodynamics, Inc.Z-1872-2026	The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.	Risk Management & CAPA

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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.