FDA enforcement

FDA recalls

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

Aesculap Inc — DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparos…Class II · 2024-01-09
Aesculap Inc — Numerous models of nonsterile hemostatic forceps: (1) REF BJ500R, …Class II · 2025-01-31
Aesculap Inc — Numerous models of nonsterile hemostatic forceps: (1) REF BH100R, Ca…Class II · 2025-01-31
Aesculap Inc — Numerous models of nonsterile hemostatic forceps: (1) REF BH198R, …Class II · 2025-01-31
Aesculap Inc — Numerous models of nonsterile hemostatic forceps: (1) REF FB458R, …Class II · 2025-01-31
Aesculap Inc — Numerous models of nonsterile hemostatic forceps: (1) REF BH951R, …Class II · 2025-01-31
Aesculap Inc — Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNE…Class II · 2026-01-15
Aesculap Inc — Aeos Robotic Digital Microscope, Product Code: PV010Class II · 2024-05-13
Aesculap, Inc. — UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgi…Class II · 2013-07-16
Aesculap, Inc. — Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)Class II · 2012-05-09
Aesculap, Inc. — Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)Class II · 2013-09-20
Aesculap, Inc. — Flexible Screw Driver SJ706R; Non Sterile; B Braun; Aesculap; …Class II · 2015-11-10
Aesculap, Inc. — Flexible Bone Awl; SJ607R; NON STERILE; B Braun Aesculap; Aesc…Class II · 2015-11-10
Aesculap, Inc. — Flexible Drill; SJ723R; NON STERILE; B Braun Aesculap; Aescula…Class II · 2015-11-10
Aesculap, Inc. — Tray Set containing multiple instruments and may contain the flexible…Class II · 2015-11-10
Aesculap, Inc. — Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap …Class II · 2013-09-10
Aesculap, Inc. — Aesculap Columbus Revision CoCr 15mm distal and posterior spacers, si…Class II · 2013-09-19
Aesculap, Inc. — The Dual Switch Valve is used for fluid drainage from the ventricles …Class II · 2014-10-24
Aesculap, Inc. — Valve XS Atrium Retractor FC429R 52154756 The Valve XS Atrium Li…Class II · 2015-11-17
Aesculap, Inc. — Aesculap Hi-Line XXS handpiece Hi-Line XXS handpieces are used wit…Class II · 2013-12-09
Aesculap, Inc. — Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/…Class II · 2012-06-04
Aesculap, Inc. — Aesculap Miethke Shunt System, miniNAV Valve: The Miethke Shunt Syste…Class III · 2014-11-11
Aesculap, Inc. — Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electro…Class II · 2013-01-18
Aesculap, Inc. — Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Ad…Class II · 2013-12-23
Aesculap, Inc. — Miethke Shunt System accessories Product Usage: - The Miethke Sh…Class II · 2014-12-17
Aesculap, Inc. — Columbus Revision Knee System, EnduRo Knee System Product Usage: …Class II · 2015-11-30
Aesculap, Inc. — Aesculap Inc.(AIC) Miethke Ventricular Catheter with Deflector/Miethk…Class II · 2014-04-21
Aesculap, Inc. — ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intend…Class II · 2013-06-18
Aesculap, Inc. — Dafilon Suture Black 10/0 (0.2) 15 cm DRM4 NS, non-sterile, non-abso…Class II · 2014-06-13
Aesculap, Inc. — S4C Occiput Torque Wrench F/Set Screw; used to tighten the S4 Cervica…Class II · 2015-07-07
AESDEX — AesDex, LLC Cardica C-Port xA PLUS Anastomosis System. Catalog Numbe…Class II · 2018-04-02
AESDEX — AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, C…Class II · 2018-04-02
Aesthetics Biomedical, Inc. — SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product…Class II · 2020-03-13
Aesthetics Systems Usa Inc — Action De Gala, FuSion Conductive Gel - Product Usage: Intended for u…Class I · 2021-08-23
Afassco Inc — The finger cots are made out of natural rubber. They are disposable …Class II · 2012-02-08
Affirm XL, Inc. — Affirm XL Nutritional Supplement, 1 and 10 count blister packs and si…Class I · 2013-04-10
Affymetrix Inc — CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent mo…Class III · 2016-04-14
Africa Imports — Organic Moringa Leaf Powder (Moringa Powder) , 4 oz. and 1 Kilogram, …Class I · 2025-11-04
African Food on Wheels Inc. — Oven Dried Fish (SCOMBEROMORUS CAVALLA); distributed to walk-in custo…Class I · 2025-11-05
AGA Gas Inc — Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases,…Class II · 2015-11-29
Agave Dream — Agave Dream Lavender 1 Pint UPC Code 8 9934900206 2Class I · 2016-11-10
Agave Dream — Agave Dream Chocolate Chip 1 Pint UPC Code 8 9934900302 1Class I · 2016-11-10
Agave Dream — Agave Dream Cappuccino 1 Pint UPC Code 8 9934900204 8Class I · 2016-11-10
Agave Dream — Agave Dream Chocolate 1 Pint UPC Code 8 9934900202 4Class I · 2016-11-10
Agave Dream — Agave Dream Vanilla 1 Pint UPC Code 8 9934900201 7Class I · 2016-11-10
Agave Dream — Agave Dream Cappuccino Ice Cream Pint UPC code: 899349002048Class I · 2016-07-19
Agebox — Agebox iKids-Growth (Day Formula) capsules, 60-count bottles, Manufac…Class II · 2025-10-28
Agebox — Agebox iKids-Growth (Night Formula), 60-count bottles, Manufactured E…Class II · 2025-10-28
AGFA Corp. — IMPAX 5.2 DB Server (running Oracle 10.1.0.4.0), medical imaging Pict…Class II · 2013-09-19
AGFA Corp. — IMPAX RIS QDOC 5.8Class II · 2014-01-08
AGFA Corp. — CR MD1.0 General Set, x-ray imager image plate. CR 10-X Image Plate …Class II · 2013-02-07
AGFA Corp. — IMPAX CV 7.8 SU3 - OCR Service. The IMPAX CV Reporting component f…Class II · 2013-03-15
AGFA Corp. — IMPAX CV Reporting Cardiac Catheterization module and IMPAX CV Outbou…Class II · 2013-03-15
AGFA Corp. — AGFA Digital Radiography X-Ray System DX-D 100 Agfa's DX-D 100 is …Class II · 2013-05-15
AGFA Corp. — IMPAX CV Pediatric Echo Reporting, IMPAX CV Echo Measurement Import v…Class II · 2014-04-30
AGFA Corp. — IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting …Class II · 2012-07-10
AGFA Corp. — AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is …Class II · 2014-06-06
AGFA Corp. — IMPAX Cardiovascular (CV) Reporting Reporting tool used for struct…Class II · 2012-07-27
AGFA Corp. — AGFA IMPAC CV DICOMStore with Media Purge Daemon (MPD) and IMPAX CV…Class II · 2012-08-09
AGFA Healthcare Corp. — IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.…Class II · 2015-09-01
AGFA Healthcare Corp. — Radiomat M+ NIF 14 x 17, Radiomat M+ NIF 35CM x 43CM, Radiomat M+ NIF…Class III · 2014-10-24
AGFA Healthcare Corp. — Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA…Class II · 2025-11-18
AGFA Healthcare Corp. — AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated f…Class II · 2016-01-20
AGFA Healthcare Corp. — DX-D600 - DXD Imaging PackageClass II · 2016-05-02
AGFA Healthcare Corp. — AGFA DX-D 100 is a mobile digital radiography x-ray systemClass II · 2015-05-29
AGFA Healthcare Corp. — IMPAX Agility. IMPAX Agility when deployed as a departmental Pictu…Class II · 2015-06-26
AGFA Healthcare Corp. — DX-D 600 - DXD Imaging Package Product Usage:Is indicated for use …Class II · 2014-07-02
AGFA Healthcare Corp. — Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is …Class III · 2014-05-13
AGFA Healthcare Corp. — Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF…Class III · 2014-07-16
AGFA Healthcare Corp. — IMPAX Cardiovascular The IMPAX CV Reporting module consists of a dat…Class II · 2016-12-22
AGFA Healthcare Corp. — Agfa Healthcare NX 3.0.8950 Imaging Processing SoftwareClass II · 2016-12-21
Agfa Healthcare NV — Enterprise Imaging XERO Viewer- software application used for referen…Class II · 2024-09-06
Agfa Healthcare NV — Enterprise Imaging Desktops Enterprise Imaging Desktops (Radiology…Class II · 2018-08-03
Agfa Healthcare NV — Agfa HealthCare Enterprise Imaging XERO ViewerClass II · 2022-12-05
Agfa N.V. — PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8,…Class III · 2019-01-25
Agfa N.V. — Agfa DX-D 100 system-Digital Radiography mobile X-ray System. A mobil…Class II · 2024-02-23
Agfa N.V. — AGFA Digital Radiography X- Ray system DR 800 with TomoSynthesis- a T…Class II · 2020-02-10
Agfa N.V. — AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic …Class II · 2019-06-27
Agfa N.V. — AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic, Ty…Class II · 2020-04-06
Agfa N.V. — DR 800. Digital Radiography X-ray System.Class II · 2024-07-29
Agfa N.V. — DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted …Class II · 2018-08-15
Agfa-Gevaert, N.V. — DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 sy…Class II · 2018-12-04
Aggredyne, Inc. — AggreGuide A-100 InstrumentClass II · 2019-07-23
Agila Specialties Private Ltd. — etomidate injection, USP, 2 mg/mL, packaged in a) 20 mg/10 mL (2 mg/m…Class II · 2014-02-14
Agilent Technologies — Brand Name: Dako CoverStainer, Dako CoverStainer CPO Product Name: C…Class II · 2024-04-02
Agilent Technologies Denmark ApS — Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready…Class II · 2025-08-11
Agilent Technologies Denmark ApS — Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready…Class II · 2025-08-11
Agilent Technologies Denmark ApS — Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready…Class II · 2025-08-11
AGILENT TECHNOLOGIES INC./US — Agilent Resolution ctDx FIRST Sample Collection Kit, 500032Class III · 2023-02-17
Agilent Technologies, Inc. — Kit Label: Anti-FITC-AP CISH Accessory Kit (Dako Omnis), Box A REF K…Class III · 2022-05-20
Agilent Technologies, Inc. — GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human referenc…Class II · 2025-03-20
Agilent Technologies, Inc. — Bond Elut OMS (Dried Matrix Spotting)' Product; Catalog model numb…Class II · 2015-06-17
Agilent Technologies, Inc. — MassHunter Quantitative Analysis Software, Version B.07.01, used with…Class II · 2018-08-15
Agiliti Health - Ellis — Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of A…Class II · 2026-01-21
Agri Exim INC. — Waah Organic Rajma MasalaClass II · 2021-05-06
AGRI-MARK INC — Cabot Creamery 8oz Extra Creamy Premium Butter, Sea Salted. Packaged …Class III · 2025-03-26
Agridient, Inc. — Vital Wheat Gluten Agridient, 50 lb. paper sackClass I · 2015-02-05
Agro Sevilla USA — H-E-B Ode to Olives, Sliced Salad Olives, 10 oz. drained weight per j…Class II · 2018-05-23
Agropur MSI Ingredients LLC — Jay Robb Unflavored Egg White Protein, Net Weight 24 oz (1.5lbs) 680g…Class I · 2018-11-16
AGROSONS LLC — Papayas Maradol cavi, Grown and Packed by: CARICA DE CAMPECHE, DISTRI…Class I · 2017-08-03