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    Propel Mini Mometasone Furoate Sinus Implant, with Straight Delivery System, REF 60044

    FDA Recall
    Open, Classified ·Intersect ENT, Inc.·Product code OWO·October 21, 2022

    Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1

    FDA Recall
    Open, Classified ·SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel·Product code GKZ·June 14, 2022

    Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.

    FDA Recall
    Open, Classified ·SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel·Product code GKZ·May 13, 2024

    The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated staining, the proposed platform provides complete blood count analysis. The Sight OLO is a compact device, designed to be automated and simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a scanning and analyzing device and a CBC test kit, including disposable cartridges and sample preparation tools. The disposable cartridge containing the blood sample is loaded into the device through the loading slot. The device is operated through the touch screen interface. The Sight OLO provides complete blood count information with 5-part differentials for white blood cell types. Specifically, the CBC parameters measured by the Sight OLO are listed below and include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%/#, LYMPH %/#, MONO %/#, EO%/# and BASO%/#. In addition, the Sight OLO signals specific WBC abnormal cases by flagging the sample.

    FDA Recall
    Open, Classified ·SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel·Product code GKZ·January 20, 2022

    Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    FDA Recall
    Open, Classified ·Oto Med Inc·Product code MXP·December 7, 2020

    Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    FDA Recall
    Open, Classified ·Oto Med Inc·Product code MXP·December 7, 2020

    Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.

    FDA Recall
    Open, Classified ·Oto Med Inc·Product code MXP·December 7, 2020

    Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: no

    FDA Recall
    Open, Classified ·SunMed Holdings, LLC·Product code OKI·December 15, 2025

    Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No

    FDA Recall
    Open, Classified ·SunMed Holdings, LLC·Product code OKI·December 15, 2025

    Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No

    FDA Recall
    Open, Classified ·SunMed Holdings, LLC·Product code OKI·December 15, 2025

    Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No

    FDA Recall
    Open, Classified ·SunMed Holdings, LLC·Product code OKI·December 15, 2025

    SENTIERO Screening2, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S2

    FDA Recall
    Open, Classified ·PATH Landsberger Str. 65 Germering Germany·Product code EWO·September 26, 2023

    SENTIERO SCREENING, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-S

    FDA Recall
    Open, Classified ·PATH Landsberger Str. 65 Germering Germany·Product code EWO·September 26, 2023

    SENTIERO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098

    FDA Recall
    Open, Classified ·PATH Landsberger Str. 65 Germering Germany·Product code EWO·September 26, 2023

    AuDX PRO, mobile medical devices for hearing examinations, Model Number SOH100098, Part Number 100098-AUP

    FDA Recall
    Open, Classified ·PATH Landsberger Str. 65 Germering Germany·Product code EWO·September 26, 2023