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    HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to lyophilization, the calibrator matrix is an MES-buffered solution. Preservative: Ofloxacin. For use in the calibration of the Hemoglobin A1c assay on the ARCHITECT c 8000 and c 4000 Systems.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code JJX·April 30, 2014

    ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300. The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (Total T33) in human serum and plasma.

    FDA Recall
    Terminated ·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code CDP·September 11, 2014

    Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbers 1.54.20 and 1.56.00

    FDA Recall
    Open, Classified ·Murata Vios, Inc.·Product code DRT·June 6, 2023

    Product Name: Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product Description: Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC): Lumipulse G -Amyloid 1-42-N Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G -Amyloid 1-42-N Plasma IRC), for the quantitative measurement of -Amyloid 1-42 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology13 by a specific two-step immunoassay method on the LUMIPULSE G System. Lumipulse G -Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC): 3 14 Tests: 3 racks, 14 IRCs per rack, 1 test per IRC. Each IRC contains (abbreviated contents): 1. Antibody-Coated Particle Solution: (Contains anti--amyloid 1-42 monoclonal antibody (mouse)-coated particles). This solution contains gelatin and turns into gel at 15C or lower, 2. Enzyme-Labeled Antibody Solution: (Contains alkaline phosphatase (ALP)-labeled anti--amyloid 1-42 monoclonal antibodies (mouse) conjugate), 3. Assay Specific Solution: (Contains detergents in 50 mM MES buffer) Component: Yes. Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio

    FDA Recall
    Open, Classified ·Fujirebio Diagnostics, Inc.·Product code SET·December 11, 2025

    Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19

    FDA Recall
    Terminated ·TriMed Inc.·Product code JDR·April 13, 2018

    Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22

    FDA Recall
    Terminated ·TriMed Inc.·Product code JDR·April 13, 2018

    TBS iNsight Version v.3.0.1 Product Usage: TBS iNsight is a medical device software that is installed on bone densitometers for analysis of bone microarchitecture and osteoporosis management.

    FDA Recall
    Terminated ·Medimaps Group Fongit Chemin des Aulx 18 Plan-les-Ouates Switzerland·Product code KGI·October 3, 2016

    Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software Version: V3.x: (1) V3.1.2, (2) V3.1.1, (3) V3.1.0, (4)V3.0.0 Product Description: TBS iNsight is a class II Medical Device software that is installed on bone densitometers for analysis of bone microarchitecture and bone health management Component: No

    FDA Recall
    Open, Classified ·Medimaps Group Fongit Chemin des Aulx 18 Plan-les-Ouates Switzerland·Product code KGI·February 3, 2025

    Alaris Infusion Pump Module, Model 8100, serviced/repaired by Biomedical Equipment Service Co. (BMES) with an impacted bezel repair part TIPA-8100-4410

    FDA Recall
    Terminated ·BioMedical Equipment Service Co (BMES)·Product code FRN·February 25, 2021

    Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x16

    FDA Recall
    Terminated ·TriMed Inc.·Product code JDR·April 13, 2018

    Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15

    FDA Recall
    Terminated ·TriMed Inc.·Product code JDR·April 13, 2018

    BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med ES Main Tower), REF: 352; BD Pyxis Anesthesia Station ES, REF: 327; BD Pyxis CII Safe ES Tower Main, REF: 1116-00; BD Pyxis CII Safe ES, Desktop PC, W-LESS SCNR, BIO, REF: 107-255-01

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code BRY·April 5, 2023

    Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.

    FDA Recall
    Open, Classified ·INCIPIO DEVICES avenue des Paquiers 16 St-Blaise Switzerland·Product code HWA·October 30, 2024

    ENVOY 500 ISE CALIBRATOR KIT, reference 55117 (contained 6 x 20 mL Calibrator High level and 6 x 20 mL Calibrator Low level). Model/Catalog Number: 55117

    FDA Recall
    Terminated ·ELITech Clinical Systems SAS Zone Industrielle des Fourneaux Sees France·Product code JIX·April 18, 2017

    Nokia BPM+ Wireless Blood Pressure Monitor Product System, measurement, blood-pressure, non-invasive

    FDA Recall
    Completed ·Withings Sas 2 rue Maurice Hartmann Issy les Moulineaux France·Product code DXN·June 11, 2018

    Harvard 2 Syringe Pump manufactured for Rita Medical (OEM) Model Number 2005-001

    FDA Recall
    Terminated ·Harvard Clinical Technology·Product code MEA·November 3, 2004

    Stryker PainPump1 Base Kit; Product number 500-100-000.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code MEA·February 3, 2006

    Freestyle Navigator Continuous Glucose Monitor System, ART 16467 Rev A, System Kit Business I, MG,(E). Abbott Item Number 70965-02, distributed by Abbott Diabetes Care Inc, Alameda, CA. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

    FDA Recall
    Terminated ·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009

    Freestyle Navigator Continuous Glucose Monitor System, ABB NAV Dutch System Kit CE RE, AND ABB SYSTEM KIT, MMOL, EMEA AND ABB09 Dutch Kit New LCD. Abbot Item Number 70966-01, distributed by Abbott Lab. Medical device indicated for continually recording interstitial fluid glucose levels in people ages 18+ with diabetes mellitus for improving diabetes management. The device is indicated to be used in hospital and home settings to aid health care.

    FDA Recall
    Terminated ·Abbott Diabetes Care, Inc.·Product code MDS·April 14, 2009

    Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Recall
    Terminated ·Dexcom Inc·Product code MDS·February 23, 2016