FDA enforcement

FDA recalls

Browse 86,532 U.S. Food & Drug Administration product recalls and enforcement actions, by company.

AB HANSON AND MOHRING — Salinity sea salt Saltwell, Saltwell 57 and Saltwell for Organic Use …Class III · 2017-06-01
AB SCIEX — Cliquid MD version 3.4 software used in conjunction with Analyst MD s…Class II · 2021-10-04
Ab Sciex — Analyst¿ MD Version 1.6.1 and 1.6.2 Software used with the following …Class II · 2016-02-24
Ab Sciex — AB Sciex Triple Quad 4500MD LC/MS/MS System, Part No. 5031257; and QT…Class II · 2016-03-25
Ab Sciex — AB Sciex API 3200MD" LC/MS/MS System. In-Vitro Diagnostic Instrument…Class II · 2016-06-16
Ab Sciex — AB SCIEX 3200MD QTRAP¿ LC/MS/MS System Mass Spectrometer for In-Vit…Class II · 2016-06-16
Ab Sciex — AB SCIEX Triple Quad 4500MD LC/MS/MS System. Mass Spectrometer for …Class II · 2016-06-16
Ab Sciex — AB SCIEX QTRAP¿ 4500MD LC/MS/MS System Mass Spectrometer for In-Vit…Class II · 2016-06-16
Ab Sciex — AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3…Class II · 2014-07-15
AB Sciex, LLC — API3200MD Mass Spectrometer, Part Number 4466230Class II · 2023-08-30
AB Sciex, LLC — 4500MD Triple Quad Mass Spectrometer, Part Number 5032522Class II · 2023-08-30
AB Sciex, LLC — Citrine QTRAP Mass Spectrometer, Part Number 5063685Class II · 2023-08-30
AB Sciex, LLC — Citrine Triple Quad Mass Spectrometer, Part Number 5063684Class II · 2023-08-30
AB ULAX — 1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Produc…Class II · 2020-09-04
AB WORLD FOODS US INC — Al'Fez Natural Tahini in 5.6oz glass jars, UPC 711464506778Class I · 2024-07-11
Abaxis Inc — Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software vers…Class II · 2019-12-11
Abbey Specialty Foods — Wicklow Gold Cheddar Nettle & Chive Cheese, 5.2 oz., plastic cryo-vac…Class I · 2024-12-18
Abbey Specialty Foods — Wicklow Gold Cheddar Tomato & Herb, 5.2 oz., plastic cryo-vac , 8 pac…Class I · 2024-12-18
Abbott — TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curv…Class I · 2025-09-10
Abbott — TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curv…Class I · 2025-09-10
Abbott — TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curv…Class I · 2025-09-10
Abbott — TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curv…Class I · 2025-09-10
Abbott — TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curv…Class I · 2025-09-10
Abbott — Abbott NT2000iX Radiofrequency (RF) generator, REF RFG-NT-2000, lesio…Class II · 2023-09-28
Abbott — Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MMClass II · 2021-11-16
Abbott — Amplatzer Steerable Delivery SheathClass II · 2021-11-09
Abbott — Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, B…Class II · 2022-03-24
Abbott — Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, B…Class II · 2022-03-24
Abbott — FIRMap" Catheter, 60mm BasketClass II · 2022-04-28
Abbott — St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, S…Class II · 2018-11-19
Abbott — Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F …Class II · 2022-06-09
Abbott — Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/06…Class II · 2025-03-17
Abbott — Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080Class II · 2025-03-17
Abbott — Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical Th…Class II · 2020-02-28
Abbott — Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 1…Class I · 2018-04-05
Abbott — Abbott Amplatzer Steerable Delivery Sheath (ASDS), REF ASDS-14F-075, …Class I · 2023-06-12
Abbott — TactiCath Quartz Contact Force Ablation Catheter, Model Numbers: PN-…Class II · 2020-05-22
Abbott Diabetes Care, Inc. — FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing…Class I · 2013-11-18
Abbott Diabetes Care, Inc. — FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic te…Class I · 2013-11-18
Abbott Diabetes Care, Inc. — FreeStyle Libre 3 App, part of Continuous Glucose Monitoring System, …Class II · 2023-02-09
Abbott Diabetes Care, Inc. — FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 Th…Class I · 2025-11-24
Abbott Diabetes Care, Inc. — FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 0035759984401…Class I · 2025-11-24
Abbott Diabetes Care, Inc. — FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 0035759984301…Class I · 2025-11-24
Abbott Diabetes Care, Inc. — FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 0035759981900…Class I · 2025-11-24
Abbott Diabetes Care, Inc. — FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use…Class I · 2014-02-19
Abbott Diabetes Care, Inc. — FreeStyle Flash Blood Glucose Monitors System. Meter made in Chi…Class I · 2014-02-19
Abbott Diabetes Care, Inc. — FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Dia…Class I · 2013-04-15
Abbott Diabetes Care, Inc. — FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component…Class I · 2023-02-13
Abbott Diabetes Care, Inc. — FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component…Class I · 2023-02-13
Abbott Diabetes Care, Inc. — FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component…Class I · 2023-02-13
Abbott Diabetes Care, Inc. — Precision Xtra Blood Glucose & Ketone Monitoring System, UDI: 0009381…Class II · 2019-11-14
Abbott Diabetes Care, Inc. — Optium EZ Blood Glucose Monitoring System, UDI: 00093815710653Class II · 2019-11-14
Abbott Diabetes Care, Inc. — FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI…Class II · 2019-11-14
Abbott Diabetes Care, Inc. — FreeStyle Libre 2 Readers, REF: 71951-01 and 71953-01, used with Free…Class II · 2023-07-12
Abbott Diabetes Care, Inc. — FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle …Class I · 2024-07-24
Abbott Diagnostics Scarborough, Inc. — Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-00…Class II · 2026-02-09
Abbott Diagnostics Scarborough, Inc. — Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0…Class II · 2025-03-04
Abbott Diagnostics Scarborough, Inc. — Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza…Class II · 2025-03-04
Abbott Diagnostics Scarborough, Inc. — Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog…Class II · 2025-03-04
Abbott Diagnostics Scarborough, Inc. — Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0…Class II · 2025-03-04
Abbott Diagnostics Scarborough, Inc. — Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza…Class II · 2025-03-04
Abbott Diagnostics Scarborough, Inc. — Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog…Class II · 2025-03-04
Abbott Diagnostics Technologies AS — Power supply provided with Afinion 2, Catalog numbers 1116553, 111655…Class II · 2020-03-23
Abbott Diagnostics Technologies AS — Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.Class II · 2024-06-17
Abbott Electrophysiology — FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size D…Class III · 2015-08-12
Abbott GmbH — ARCHITECT Anti-HCV Reagent Kit, List Numbers: a) 1L79-25, b) 1L79-35Class II · 2024-03-04
Abbott GmbH — Alinity i Anti-HCV Reagent Kit, List Number 08P0521Class II · 2024-03-04
Abbott Gmbh & Co. KG — Alinity ci Level Sensor, Bulk SolutionClass II · 2019-09-16
Abbott Gmbh & Co. KG — Accessory kit, Alinity i containing Alinity ci Level Sensor, Bulk Sol…Class II · 2019-09-16
Abbott Gmbh & Co. KG — Accessory kit, Alinity c containing Alinity ci Level Sensor, Bulk Sol…Class II · 2019-09-16
Abbott Gmbh & Co. KG — ARCHITECT HAVAB-G Calibrator, REF 6L27-01Class II · 2019-11-07
Abbott GmBH & Co. KG — Alinity c Carbon Dioxide Reagent Kit, Produced for Abbott by Sekisui…Class II · 2019-10-23
Abbott Gmbh & Co. KG — Alinity i Processing Module, (a) Part Number 03R65-01 (b) Part Num…Class II · 2018-12-20
Abbott Gmbh & Co. KG — Abbott Alinity i Processing Module LN 03R65-01 - Product Usage: The A…Class II · 2019-02-26
Abbott Gmbh & Co. KG — Abbott Alinity c Processing Module LN 03R67-01 - Product Usage: The A…Class II · 2019-02-26
Abbott Gmbh & Co. KG — Abbott Alinity ci-series System Control Module software version 2.5.1…Class II · 2019-03-07
Abbott Gmbh & Co. KG — Alinity i Processing Module, 03R65 01, with the below components. …Class II · 2019-04-05
Abbott Gmbh & Co. KG — LN 3R70-01; software version 2.6.2 and earlier. The software is used…Class II · 2020-01-24
Abbott Gmbh & Co. KG — ARCHITECT DHEA-S Reagent Product Usage: It is a chemiluminescent …Class II · 2017-12-14
Abbott Gmbh & Co. KG — Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The…Class II · 2019-04-15
Abbott Gmbh & Co. KG — ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.Class II · 2020-03-09
Abbott Gmbh & Co. KG — ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements o…Class II · 2020-04-24
Abbott Gmbh & Co. KG — The Alinity ci-series System Control Modules which are configured wit…Class II · 2019-05-21
Abbott Gmbh & Co. KG — Alinity ci -series System Control¿Module, Part Number 03R70 01 Pro…Class II · 2019-06-10
Abbott Gmbh & Co. KG — Alinity C, Processing Module. Chemistry analyzer for in-vitro diagno…Class II · 2020-05-12
Abbott Gmbh & Co. KG — Alinity ci series System Control Module (SCM); LN 3R70-01 Alinity ci…Class II · 2020-06-19
Abbott Ireland Diagnostics Division — ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottl…Class II · 2014-09-11
Abbott Ireland Diagnostics Division — Alinity i TSH Reagent Kit, List Number 07P4830Class II · 2018-11-21
Abbott Ireland Diagnostics Division — Alinity i Free T4 Reagent Kit, List Number 07P7030Class II · 2018-11-21
Abbott Ireland Diagnostics Division — Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121Class II · 2018-11-21
Abbott Ireland Diagnostics Division — Alinity i Estradiol Reagent Kit, List Number 07P5020Class II · 2018-11-21
Abbott Ireland Diagnostics Division — Alinity i Progesterone Reagent Kit, List Number 08P3620Class II · 2018-11-21
Abbott Ireland Diagnostics Division — Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532Class II · 2018-11-21
Abbott Ireland Diagnostics Division — ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i200…Class II · 2018-10-12
Abbott Ireland Diagnostics Division — ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i20…Class II · 2018-10-12
Abbott Ireland Diagnostics Division — Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT…Class II · 2019-02-05
Abbott Ireland Diagnostics Division — Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Est…Class II · 2019-02-05
Abbott Ireland Diagnostics Division — Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i…Class II · 2018-11-21
Abbott Ireland Limited — Alinity i Anti-TPO Reagent Kit, List Number 09P3521Class III · 2023-04-24
Abbott Laboratories — Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 table…Class II · 2012-12-04