FDA enforcement

FDA recalls

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

Abbott Laboratories — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog…Class II · 2025-03-18
Abbott Laboratories — ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27Class II · 2022-07-26
Abbott Laboratories — ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each).…Class II · 2014-02-12
Abbott Laboratories — ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) …Class II · 2014-02-12
Abbott Laboratories — "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0…Class II · 2019-05-22
Abbott Laboratories — Alkaline Wash, List number 9D31-20, a cleaning solution used by the A…Class II · 2015-05-11
Abbott Laboratories — The ARCHITECT Estradiol Kit Intended to measure estradiol, an est…Class II · 2016-03-24
Abbott Laboratories — ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the di…Class III · 2020-04-01
Abbott Laboratories — ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the…Class III · 2020-04-01
Abbott Laboratories — ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the…Class III · 2020-04-01
Abbott Laboratories — ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list …Class II · 2012-05-30
Abbott Laboratories — ICT Serum Calibrator REF 146-03. For use in the calibration of th…Class II · 2014-07-22
Abbott Laboratories — ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibr…Class III · 2019-05-24
Abbott Laboratories — ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls…Class III · 2019-05-24
Abbott Laboratories — REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase re…Class II · 2021-06-10
Abbott Laboratories — REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with …Class II · 2021-06-10
Abbott Laboratories — REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with …Class II · 2021-06-10
Abbott Laboratories — REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with …Class II · 2021-06-10
Abbott Laboratories — ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Ab…Class II · 2015-06-11
Abbott Laboratories — Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage:…Class II · 2020-04-02
Abbott Laboratories — Alinity ci-series System Control Module clinical chemistry and immuno…Class II · 2021-07-26
Abbott Laboratories — ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminesc…Class II · 2017-04-18
Abbott Laboratories — Alinity hq Analyzer, REF: 09P68-01Class II · 2024-06-14
Abbott Laboratories Inc. (St Jude Medical) — TactiSys Quartz Equipment (with software version 1.7) Model: PN-004…Class II · 2019-04-05
Abbott Laboratories Inc. (St Jude Medical) — NeuroTherm NT2000iX Radiofrequency (RF) Generator, Model Number RFG-N…Class II · 2021-04-22
Abbott Laboratories Inc. (St Jude Medical) — v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris Syste…Class II · 2021-05-05
Abbott Laboratories Inc. (St Jude Medical) — v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" Syst…Class II · 2021-05-05
Abbott Laboratories Inc. (St Jude Medical) — WorkMate Claris v.1.2 Upgrade Kits, Model Numbers H800007 and H800012Class II · 2021-05-05
Abbott Laboratories, Inc — ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name…Class II · 2015-01-15
Abbott Laboratories, Inc — Clinical Chemistry Phosphorus Reagent The Phosphorus assay is use…Class II · 2013-08-12
Abbott Laboratories, Inc — Lipase Reagent, 7D80. Used to measure lipase in human serum on the…Class II · 2014-04-07
Abbott Laboratories, Inc — ARCHITECT i2000SR System The Abbott ARCHITECT System is intended fo…Class II · 2015-09-09
Abbott Laboratories, Inc — ARCHITECT c4000 part number 02P24; ARCHITECT c8000 part number 01G06;…Class II · 2017-09-29
Abbott Laboratories, Inc — Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinica…Class II · 2017-09-29
Abbott Laboratories, Inc — Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (0…Class II · 2022-02-03
Abbott Laboratories, Inc — ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to…Class II · 2017-12-08
Abbott Laboratories, Inc — ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to…Class II · 2017-12-08
Abbott Laboratories, Inc — ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component …Class II · 2017-12-08
Abbott Laboratories, Inc — ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium as…Class II · 2019-01-02
Abbott Laboratories, Inc — ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBs…Class II · 2012-12-18
Abbott Laboratories, Inc — Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.Class II · 2018-07-18
Abbott Laboratories, Inc — Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.Class II · 2018-07-18
Abbott Laboratories, Inc — Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Us…Class II · 2018-07-17
Abbott Laboratories, Inc — Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Us…Class II · 2018-07-17
Abbott Laboratories, Inc — Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product U…Class II · 2018-07-17
Abbott Laboratories, Inc — Clinical Chemistry Phenobarbital, list number 1E08Class II · 2012-11-16
Abbott Laboratories, Inc — Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage:…Class II · 2018-08-28
Abbott Laboratories, Inc — ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chem…Class II · 2019-05-01
Abbott Laboratories, Inc — C3 is an in vitro diagnostic assay for the quantitative determination…Class II · 2018-05-16
Abbott Laboratories, Inc — Immunoglobulin A is an in vitro diagnostic assay for the quantitative…Class II · 2018-05-16
Abbott Laboratories, Inc — Immunoglobulin G is an in vitro diagnostic assay for the quantitative…Class II · 2018-05-16
Abbott Laboratories, Inc — Immunoglobulin M is an in vitro diagnostic assay for the quantitative…Class II · 2018-05-16
Abbott Laboratories, Inc — Apolipoprotein A1 is an in vitro diagnostic assay for the quantitativ…Class II · 2018-05-16
Abbott Laboratories, Inc — C4 is an in vitro diagnostic assay for the quantitative determination…Class II · 2018-05-16
Abbott Laboratories, Inc — The,K -ASSAY HP assay is intended for the quantitative determinatio…Class II · 2018-05-16
Abbott Laboratories, Inc — Apolipoprotein B is an in vitro diagnostic assay for the quantitative…Class II · 2018-05-16
Abbott Laboratories, Inc — Transferrin is an in vitro diagnostic assay for the quantitative dete…Class II · 2018-05-16
Abbott Laboratories, Inc — Alinity s System REF 06P16-01. An automated immunoassay analyzer fo…Class II · 2021-07-12
Abbott Laboratories, Inc — APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, …Class II · 2018-09-07
Abbott Laboratories, Inc. — CardioMEMS HF System Hospital and Patient Electronics Units: (a) Pat…Class II · 2018-06-14
Abbott Medical — Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400Class II · 2025-10-06
Abbott Medical — Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400Class II · 2025-10-06
Abbott Medical — Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart …Class II · 2024-10-17
Abbott Medical — Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Ster…Class II · 2024-10-17
Abbott Medical — Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 2…Class II · 2024-10-17
Abbott Medical — Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, …Class II · 2024-10-17
Abbott Medical — Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Ster…Class II · 2024-10-17
Abbott Medical — Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmit…Class III · 2024-10-01
Abbott Medical — Merlin@home with the MerlinOnDemand capability Transmitter REF EX1150…Class III · 2024-10-01
Abbott Medical — Radiofrequency Grounding Pad, REF RF-DGP-LClass II · 2019-10-14
Abbott Medical — CLASSIC Radiofrequency Cannula - Curved, 10 cm, SMK Compatible Electr…Class II · 2019-11-11
Abbott Medical — The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programme…Class II · 2024-11-21
Abbott Medical — Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303Class II · 2019-12-09
Abbott Medical — Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm…Class II · 2019-12-09
Abbott Medical — Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI…Class II · 2025-02-15
Abbott Medical — Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEOClass II · 2024-02-05
Abbott Medical — Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, …Class II · 2024-05-16
Abbott Medical — Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile E…Class II · 2024-05-16
Abbott Medical — Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, …Class II · 2024-05-16
Abbott Medical — Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile …Class II · 2024-05-16
Abbott Medical — Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, …Class II · 2024-05-16
Abbott Medical — Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, …Class II · 2024-05-16
Abbott Medical — Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, …Class II · 2024-05-16
Abbott Medical — Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile…Class II · 2024-05-16
Abbott Medical — Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile…Class II · 2024-05-16
Abbott Medical — Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile…Class II · 2024-05-16
Abbott Medical — Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO…Class II · 2024-05-16
Abbott Medical — Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, R…Class II · 2024-05-16
Abbott Medical — Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, R…Class II · 2024-05-16
Abbott Medical — Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programm…Class II · 2026-05-12
Abbott Medical — Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO,…Class II · 2024-05-22
Abbott Medical — Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO,…Class II · 2024-05-22
Abbott Medical — Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO,…Class II · 2024-05-22
Abbott Medical — Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO,…Class II · 2024-05-22
Abbott Medical — Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously know…Class I · 2023-07-18
Abbott Medical — Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously know…Class I · 2023-07-18
Abbott Medical — Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Descr…Class I · 2023-07-18
Abbott Medical — Proclaim Plus 7 Implantable Pulse Generator REF 3672 Product Descr…Class I · 2023-07-18
Abbott Medical — Proclaim DRG Implantable Pulse Generator REF 3664 Product Descript…Class I · 2023-07-18
Abbott Medical — Infinity 5 Implantable Pulse Generator REF 6660 Product Descriptio…Class I · 2023-07-18