FDA enforcement

FDA recalls

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

Abbott Medical — Infinity 7 Implantable Pulse Generator REF 6662 Product Descriptio…Class I · 2023-07-18
Abbott Medical — Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA5…Class II · 2023-08-16
Abbott Medical — Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D…Class II · 2023-08-16
Abbott Medical Optics Inc (AMO) — Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hya…Class II · 2014-11-06
Abbott Medical Optics Inc (AMO) — AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable …Class II · 2012-12-20
Abbott Medical Optics Inc. (AMO) — Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10…Class II · 2017-04-01
Abbott Medical Optics Inc. (AMO) — Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014,…Class II · 2017-04-01
Abbott Medical Optics Inc. (AMO) — Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012Class II · 2017-04-01
Abbott Medical Optics Inc. (AMO) — Healon 5 Pro, Part No. 10270015Class II · 2017-04-01
Abbott Medical Optics Inc. (AMO) — Healon Pro, Part No. 10270012Class II · 2017-04-01
Abbott Medical Optics Inc. (AMO) — Healon V, Part No. 10290045Class II · 2017-04-01
Abbott Medical Optics Inc. (AMO) — AMO 25GA Vitrectomy Cutter (Model Number NGP0025) and AMO 20GA Vitrec…Class II · 2017-03-30
Abbott Medical Optics Inc. (AMO) — SENSAR Foldable IOL with OptiEdge Design, Model No. AR40e The produc…Class II · 2016-08-26
Abbott Medical Optics Inc. (AMO) — TECNIS Multifocal 1-Piece Intraocular Lens, Model No. ZKB00, ZLB00; …Class II · 2016-08-26
Abbott Medical Optics Inc. (AMO) — TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The pro…Class II · 2016-08-26
Abbott Medical Optics Inc. (AMO) — TECNIS 1-Piece IOL, Model No. ZCB00 The product is indicated for imp…Class II · 2016-08-26
Abbott Medical Optics Inc. (AMO) — TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The…Class II · 2016-08-26
Abbott Medical Optics Inc. (AMO) — SENSAR 1-Piece IOL, Model No. AAB00 The product is indicated for imp…Class II · 2016-08-26
Abbott Medical Optics Inc. (AMO) — TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Mo…Class II · 2016-08-26
Abbott Medical Optics Inc. (AMO) — TECNIS OptiBlue 1-Piece IOL with the TECNIS iTec Preloaded Delivery …Class II · 2016-08-26
Abbott Medical Optics Inc. (AMO) — TECNIS Multifocal Foldable Acrylic Intraocular Lens, Model No. ZMA00 …Class II · 2016-08-26
Abbott Medical Optics Inc. (AMO) — AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design, Model No. Z…Class II · 2016-08-26
Abbott Medical Optics, Inc. — STAR Excimer Laser System, Model: STAR S2, Catalog Number: 0030-1479,…Class II · 2013-09-16
Abbott Medical Optics, Inc. — STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number:…Class II · 2013-09-16
Abbott Medical Optics, Inc. — STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4…Class II · 2013-09-16
Abbott Medical Optics, Inc. — STAR Excimer Laser System, Model STAR S4 IR, Catalog Number: 0030-486…Class II · 2013-09-16
Abbott Medical Optics, Inc. — OptiMedica Catalys Precision Laser System; Model No(s). Catalys-U (US…Class II · 2015-02-20
Abbott Medical Optics, Inc. — STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufactu…Class II · 2013-05-28
Abbott Medical Optics, Inc. — STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg …Class II · 2013-05-28
Abbott Medical Optics, Inc. — STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing US…Class II · 2013-05-28
Abbott Medical Optics, Inc. — Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CM…Class II · 2013-05-23
Abbott Molecular — Abbott m2000sp, an automated system for performing sample preparation…Class II · 2014-10-23
Abbott Molecular — Abbott m2000sp Instrument; an automated fluid handling system for per…Class II · 2012-12-04
Abbott Molecular — The Abbott m2000sp is an automated system for performing sample prepa…Class II · 2013-11-23
Abbott Molecular — The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is …Class III · 2013-03-28
Abbott Molecular — Abbott Molecular Bar Code Scanner User's Guide; instructions for sett…Class II · 2012-01-31
Abbott Molecular — 5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated F…Class II · 2014-06-19
Abbott Molecular, Inc. — Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) …Class I · 2021-09-02
Abbott Molecular, Inc. — Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay)…Class I · 2021-09-02
Abbott Molecular, Inc. — Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 …Class I · 2021-09-02
Abbott Molecular, Inc. — Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 …Class I · 2021-09-02
Abbott Molecular, Inc. — Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Ple…Class I · 2021-09-02
Abbott Molecular, Inc. — Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product…Class II · 2024-09-12
Abbott Molecular, Inc. — Abbott Alinity m STI AMP Kit, used with the Alinity m System, product…Class II · 2024-09-12
Abbott Molecular, Inc. — Alinity m System, REF 08N53-002, For In Vitro Diagnostic UseClass II · 2022-10-12
Abbott Molecular, Inc. — Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50…Class II · 2023-10-30
Abbott Molecular, Inc. — Alinity m System, Part No. 08N53-002Class II · 2021-12-06
Abbott Molecular, Inc. — Alinity m System, Part No. 08N53-002Class II · 2021-12-06
Abbott Molecular, Inc. — Alinity m System, Part No. 08N53-002Class II · 2021-12-06
Abbott Molecular, Inc. — Alinity m System, Part No. 08N53-002Class II · 2021-12-06
Abbott Molecular, Inc. — Alinity m Integrated Reaction Units (IRU)Class II · 2022-02-11
Abbott Molecular, Inc. — Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096Class II · 2022-11-22
Abbott Molecular, Inc. — Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090Class II · 2022-11-22
Abbott Molecular, Inc. — Alinity m HBV Application Specification File (US and CE)Class II · 2022-03-04
Abbott Molecular, Inc. — Alinity m HBV AMP Kit (US and CE)Class II · 2022-03-04
Abbott Molecular, Inc. — Alinity m System. The Alinity m System is designed to automate t…Class II · 2022-12-09
Abbott Molecular, Inc. — In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Prob…Class III · 2024-02-01
Abbott Molecular, Inc. — In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) Spect…Class III · 2024-02-01
Abbott Molecular, Inc. — Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28…Class III · 2024-02-01
Abbott Molecular, Inc. — Abbott Alinity m System, REF 08N53-002, containing Amplification Dete…Class II · 2022-11-11
Abbott Molecular, Inc. — The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.Class II · 2022-07-19
Abbott Molecular, Inc. — Alinity m System, Part Number: 08N53-002Class II · 2024-03-20
Abbott Molecular, Inc. — The Alinity m System is designed to automate the steps for nucleic ac…Class II · 2025-03-20
Abbott Molecular, Inc. — Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contain…Class II · 2022-08-19
Abbott Molecular, Inc. — Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79…Class II · 2025-04-28
Abbott Molecular, Inc. — Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex rea…Class II · 2025-04-28
Abbott Molecular, Inc. — Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53…Class II · 2021-08-04
Abbott Nutrition — The product is labeled as follows: PediaSure Grow & Gain Vanilla, Uni…Class II · 2016-03-10
Abbott Nutrition — Promote with Fiber Vanilla, 8oz metal canClass II · 2016-05-09
Abbott Nutrition — Oxepa, 8oz metal canClass II · 2016-05-09
Abbott Nutrition — Nepro Vanilla High Protein , 8oz metal canClass II · 2016-05-09
Abbott Nutrition — Nepro Vanilla , 8oz metal canClass II · 2016-05-09
Abbott Nutrition — Vital High Protein, 8oz metal canClass II · 2016-05-09
Abbott Nutrition — Nepro Mixed Berry, 8oz metal canClass II · 2016-05-09
Abbott Nutrition — Similac Human Milk Fortifier Powder, .9 g packets. Label reads in par…Class II · 2013-10-11
ABBOTT NUTRITION — Similac Alimentum packaged in 32 fluid ounce re-closable plastic bott…Class II · 2022-08-16
Abbott Nutrition, Division of Abbott Laboratories — Similac Pro-Advance Infant Formula with Iron, Milk-Based, Ready to Fe…Class III · 2020-06-11
Abbott Nutrition, Division of Abbott Laboratories — Similac Pro-Sensitive, 2 fl. oz. plastic bottles packed 12 per carton.Class II · 2019-08-16
Abbott Point of Care Canada Limited — Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac tro…Class II · 2012-11-01
Abbott Point Of Care Inc. — Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List N…Class III · 2012-07-19
Abbott Point Of Care Inc. — Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton,…Class II · 2013-10-28
Abbott Point Of Care Inc. — Abbott i-STAT CG8+ Cartridges intended for use in the in vitro quanti…Class II · 2018-09-13
Abbott Point Of Care Inc. — i-STAT cTnI cartridgeClass II · 2019-10-16
Abbott Point Of Care Inc. — Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measure…Class II · 2020-12-22
Abbott Point Of Care Inc. — Abbott i-STAT EG7+ cartridge-IVD. Intended for the quantitative meas…Class II · 2020-12-22
Abbott Point Of Care Inc. — i-STAT DE handheld data processing module for clinical use, Software …Class II · 2017-09-12
Abbott Point Of Care Inc. — i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749…Class II · 2020-01-15
Abbott Point Of Care Inc. — i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002…Class II · 2020-01-15
Abbott Point Of Care Inc. — i-STAT G3+ cartridge (blue), List No. 03P78-50, UDI (01) 000547490022…Class II · 2020-01-14
Abbott Point Of Care Inc. — i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the…Class II · 2014-01-01
Abbott Point Of Care Inc. — iStat1 Analyzer Abbott Point of Care, Princeton, NJ 08540 Model 2…Class II · 2011-09-08
Abbott Point Of Care Inc. — i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, N…Class II · 2011-09-08
Abbott Point Of Care Inc. — Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Mode…Class II · 2011-09-08
Abbott Point Of Care Inc. — i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540Class II · 2011-09-08
Abbott Point Of Care Inc. — i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 …Class II · 2011-09-08
Abbott Point Of Care Inc. — Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Prin…Class II · 2011-09-08
Abbott Point Of Care Inc. — i-STAT EG7+ cartridge; List Number: 03P76-25;Class II · 2026-04-01
Abbott Point Of Care Inc. — i-STAT EG6+ cartridge; List Number: 03P77-25;Class II · 2026-04-01
Abbott Point Of Care Inc. — i-STAT G3+ cartridge; List Number: 03P78-26;Class II · 2026-04-01
Abbott Point Of Care Inc. — I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-S…Class II · 2011-01-01