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    HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.

    FDA Recall
    Open, Classified ·Coltene Whaledent Inc·Product code EJG·June 3, 2020

    HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.

    FDA Recall
    Open, Classified ·Coltene Whaledent Inc·Product code EJG·June 3, 2020

    HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.

    FDA Recall
    Open, Classified ·Coltene Whaledent Inc·Product code EJG·June 3, 2020

    HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam forceps are intended to be used in conjunction with the rubber dental dam and the dental dam clamps. The forceps are used to place and remove the dental dam clamps from the rubber dental dam.

    FDA Recall
    Open, Classified ·Coltene Whaledent Inc·Product code EJG·June 3, 2020

    NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code ETN·April 29, 2022

    NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code ETN·April 29, 2022

    NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306

    FDA Recall
    Open, Classified ·Medtronic Xomed, Inc.·Product code ETN·April 29, 2022

    Medtronic HVAD Pump Implant Kits, labeled as: a. PUMP 1103, b. PUMP 1104, c. PUMP 1104JP, d. PUMP 1100, e. Model 1101, f. Model 1102, g. Model 1104CA-CLIN, h. Model 1205, i. Model MCS1705PU

    FDA Recall
    Open, Classified ·Heartware, Inc.·Product code DSQ·November 19, 2020

    Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchronization Therapy Defibrillator: NxT HF CRT-D REF CDHFA600Q Entrant HF Cardiac Resynchronization Therapy Defibrillator : HF CRT-D REF CDHFA300Q The primary function of ICDs and CRT-Ds are to treat life-threatening ventricular tachyarrhythmias via anti-tachycardia pacing (ATP), or cardioversion/defibrillation. Implantable Cardioverter Defibrillators (ICDs) can either be a dual chamber (also known as DR if rate responsive) device that is connected to a right atrial (RA) pacing lead and right ventricular defibrillation lead or single chamber ICD (also known as VR if rate responsive) with only a defibrillation lead in the right ventricle (RV). The ICD, more generally known as an implantable pulse generator (IPG), is typically implanted in a subcutaneous device pocket located in the pectoral region and is attached to the pacing/defibrillator leads that are implanted through the transvenous technique with the distal tips positioned in the RA (dual chamber) and RV. Cardiac Resynchronization Therapy Defibrillator (CRT-D) systems consist of a right atrial (RA) pacing lead, a right ventricular (RV) defibrillation lead, as well as a third lead placed in the coronary venous system overlying the left ventricle (LV) to improve ventricular resynchronization through biventricular pacing for treatment of heart failure. CRT-D devices, more generally known as an implantable pulse generator (IPG), are typically implanted in a subcutaneous device pocket located in the pectoral region and are attached to the pacing/defibrillator leads that are implanted through transvenous technique.

    FDA Recall
    Open, Classified ·Abbott Medical·Product code NIK·August 16, 2023

    Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q Neutrino VR Implantable Cardioverter Defibrillator: NxT VR ICD REF CDVRA600Q Neutrino DR Implantable Cardioverter Defibrillator: NxT DR ICD REF CDDRA600Q Entrant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA300Q Entrant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA300Q The primary function of ICDs and CRT-Ds are to treat life-threatening ventricular tachyarrhythmias via anti-tachycardia pacing (ATP), or cardioversion/defibrillation. Implantable Cardioverter Defibrillators (ICDs) can either be a dual chamber (also known as DR if rate responsive) device that is connected to a right atrial (RA) pacing lead and right ventricular defibrillation lead or single chamber ICD (also known as VR if rate responsive) with only a defibrillation lead in the right ventricle (RV). The ICD, more generally known as an implantable pulse generator (IPG), is typically implanted in a subcutaneous device pocket located in the pectoral region and is attached to the pacing/defibrillator leads that are implanted through the transvenous technique with the distal tips positioned in the RA (dual chamber) and RV. Cardiac Resynchronization Therapy Defibrillator (CRT-D) systems consist of a right atrial (RA) pacing lead, a right ventricular (RV) defibrillation lead, as well as a third lead placed in the coronary venous system overlying the left ventricle (LV) to improve ventricular resynchronization through biventricular pacing for treatment of heart failure. CRT-D devices, more generally known as an implantable pulse generator (IPG), are typically implanted in a subcutaneous device pocket located in the pectoral region and are attached to the pacing/defibrillator leads that are implanted through transvenous technique.

    FDA Recall
    Open, Classified ·Abbott Medical·Product code LWS·August 16, 2023

    INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530 INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W INTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Blue 4-Row 3.5 mm Xi|X REF 48230B

    FDA Recall
    Open, Classified ·Intuitive Surgical, Inc.·Product code NAY·October 7, 2022

    Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus.

    FDA Recall
    Open, Classified ·Hologic, Inc·Product code NJR·March 18, 2022

    LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW NE 3.5D, REF: 8735-80NNE; LEGACY SMARTBASE, NE 3.5D 2MML, REF: 8735-82NE LEGACY SMARTBASE NARROW NE 4.5D, REF: 8745-80NNE; LEGACY SMARTBASE. NE 4.5D, REF: 8745-82NE;

    FDA Recall
    Open, Classified ·Implant Direct Sybron Manufacturing LLC·Product code NHA·May 2, 2023

    Product: STA Liatest D-Di; REF: 00515;

    FDA Recall
    Open, Classified ·Diagnostica Stago, Inc.·Product code DAP·September 12, 2025

    Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA - Liatest D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R, STA Compact and STA Satellite analyzers by professional laboratory personnel. The STA - Liatest D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No

    FDA Recall
    Open, Classified ·Diagnostica Stago, Inc.·Product code DAP·February 5, 2026

    D-Dimer Test

    FDA Recall
    Open, Classified ·GET TESTED INTERNATIONAL AB 59334 Vastervik Lysingsvagen 18 Vastervik Sweden·Product code DAP·November 3, 2025

    VIDAS DEX@, Dimer Exclusion II, REF 30455-01

    FDA Recall
    Open, Classified ·bioMerieux, Inc.·Product code DAP·September 22, 2021

    Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.

    FDA Recall
    Open, Classified ·Hologic, Inc.·Product code NJR·December 13, 2024

    Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No

    FDA Recall
    Open, Classified ·Hologic, Inc.·Product code OYB·February 18, 2026

    18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;

    FDA Recall
    Open, Classified ·DAYE (ANNE'S DAY LTD) Biscuit Factory Business Complex 100 Drummond Road London United Kingdom·Product code HEB·February 17, 2025