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    KODAK T-MAT G/RA Film, Catalog/REF # 151 0023, 24x30 cm, 5-100 Sheet Boxes FOLHAS/Hojas, Made in U.S.A. by Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- Device Listing # E420904 Intended use: Imaging film

    FDA Recall
    Terminated ·Carestream Health, Inc.·Product code IWZ·March 12, 2010

    KODAK T-MAT L/RA Film, Catalog/REF # 181 4631, 35x43 cm 5-100 Sheet Boxes Folhas/Hojas, Made in U.S.A. by Carestream Health, Inc. 150 Verona Street, Rochester, NY 14608 --- Device Listing # E420904 Intended use: Imaging film

    FDA Recall
    Terminated ·Carestream Health, Inc.·Product code IWZ·March 12, 2010

    GE Healthcare, Optima MR450w 1.5T MR systems The GE Signa MR750 System is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa MR750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and organs of the entire body, including, but not limited to, head, neck, TMVJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the GE Signa MR750 System reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images when interpreted by a trained physician yield information that may assist in diagnosis. The indications for use for the 3.0T GE Signa MR750 System are similar to those for the Signa HDx Magnetic Resonance System and the Siemens MAGNETOM Verio MR System.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·November 18, 2010

    Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567

    FDA Recall
    Open, Classified ·Tobii Dynavox Llc·Product code ILQ·February 24, 2023

    Synapse CV 6. with AR. A web-based application as the primary user interface for the processing of medical images.

    FDA Recall
    Open, Classified ·FUJIFILM Healthcare Americas Corporation·Product code LLZ·January 3, 2024

    life+cel Replacement Battery for Cardiac Science Powerheart AED G3 OEM P/N: 9146-001, Lithium Sulfur Dioxide, Part # 7L877, Voltage 12V, 7.5 amps; Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.

    FDA Recall
    Terminated ·Exocomm Tech Grp·Product code MKJ·September 3, 2007

    life+cel, Replacement battery for Cardiac Science FirstSave Survivalink; OEM P/N:9141-001, Part #: 2L561, Lithium Sulfur Dioxide, Voltage 12V, 7.5 amps., Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.

    FDA Recall
    Terminated ·Exocomm Tech Grp·Product code MKJ·September 3, 2007

    All Med Medical 20ga x 1" RA Hub Needle Model #M201H Reorder #55-2030 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.

    FDA Recall
    Terminated ·Multi-Med, Inc.·Product code FMI·August 30, 2010

    All Med Medical 22ga x 1" RA Hub Needle Model #M221H Reorder #55-2230 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.

    FDA Recall
    Terminated ·Multi-Med, Inc.·Product code FMI·August 30, 2010

    All Med Medical 19ga x 1" RA Hub Needle Model #M191H Reorder #55-1930 Intended to be used to inject fluids into, withdraw fluids from inside the vascular space through a subcutaneously implanted port.

    FDA Recall
    Terminated ·Multi-Med, Inc.·Product code FMI·August 30, 2010

    Modera Modular Pedicle Screw System Shank Insertion Instrument, 3-107-07

    FDA Recall
    Terminated ·New Era Orthopaedics, LLc·Product code MNI·February 13, 2017

    Fresenius 2008T BlueStar Hemodialysis Machine Part Number Description: 191124 2008T HD SYS. CDX BLUEST AR; 191126 2008T HD SYS. CDX W/BIBAG BLUEST AR; 191128 2008T HD SYS. W/O CDX BLUEST AR; 191130 2008T HD SYS. W/O CDX W/BIBAG BLUEST AR

    FDA Recall
    Open, Classified ·Fresenius Medical Care Holdings, Inc.·Product code KDI·March 12, 2020

    NeiMed NasoGel for DRY NOSES UDI-DI/UPC code: 00705928045309 SKU GSP30-2R-48-ENU-USL GSP30-0R-96-ENU-USL GSP30-ARA-INTL GSP30-SWE-INTL GSP30-ENG-INT GSP30-MAL-INTL GSP30-SPA-INT NasoGel Spray is a saline-based gel formula that can be sprayed to moisturize and lubricate dry and irritated anterior or front of nasal passages caused by dry climate and indoor heat.

    FDA Recall
    Open, Classified ·Neilmed Pharmaceuticals Inc·Product code KCJ·December 28, 2024

    Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). The system, which includes a radiologic / urologic treatment table, maybe used for urological treatment, planning and diagnostic procedures, including but not limited to.

    FDA Recall
    Terminated ·Hans Pausch Rontgengeratebau Gmbh Graf Zeppelin Strasse 1 Erlangen Germany·Product code JAA·March 14, 2017

    BD 30G1/2 PrecisionGlide Needle;Catalog/Lot Number: 305106. Needles are intended for use in aspiration and injection of medications.

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code GAA·August 24, 2010

    VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code GAA·December 17, 2019

    Hobbs Transbronchial Aspiration Needle Catalog Number: 4621

    FDA Recall
    Open, Classified ·Hobbs Medical, Inc.·Product code GAA·July 29, 2022

    Aspirated Cyto-Histological Biopsy needle

    FDA Recall
    Completed ·M.D.L. S.r.l. Via Tavani N. 1/A Delebio Italy·Product code GAA·August 5, 2021

    Angiotech Breast Localization Needles: A) Accura BLN and Accura II BLN with Stiffening Cannula, STERILE. Product Numbers: BLN2003, BLN2005, BLN20075, BLN2103, BLN2105, BLN21075, 266050, 266075. 510k K974741 Qty Dist. - 14,800. B) Hawkins I BLN; Hawkins II Hardware BLN, Hawkins II Flexstrand BLN. STERILE. Product Numbers: 251050, 251075, 251100, 242050, 242075, 252050, 252075. 510k K870523 Qty Dist. - 6,420. C) Hawkins III Hardwire BLN, Hawkins III Hardwire BLN with Echogenic Tip, Hawkins III Flextrand BLN. STERILE. Product Numbers: 243030, 243050, 243075, 244030, 244050, 244075, 253030, 253050, 253075. 510k 870523 Qty Dist. - 15,440. D) Homer Mammalok Gold Improved Tensile Strength. STERILE. Product Numbers: 231030G, 231050G, 231075G, 231100G, 231125G. 510k Exempt. Qty Dist. - 21,780. E) "D" Wire BLN. STERILE. Product Numbers: BLND20075. 510k K974741 Qty Dist. 230 MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended use: Breast Localization Needle

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code GAA·September 1, 2009

    (1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) VitreQ 20G BF Brush Needles-REF: BF20.D52 GTIN: 8719214221102

    FDA Recall
    Terminated ·Vitreq Bv Seggelant-Noord 2 Vierpolders Netherlands·Product code GAA·December 17, 2019