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    FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QBH·December 14, 2023

    FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit)

    FDA Recall
    Open, Classified ·BioFire Diagnostics, LLC·Product code QDS·December 14, 2023

    Cook Esophageal Dilator Set --------------------------------------Small label applied by OEM supplier: C CEDS 58 70 * Use By 2008/04 * Lot No. F1734513 * Sterile * Rx only * Cook *** Large product label applied at Cook Endoscopy: Cook Esophageal Dilator Set * Catheter Diameter: 20 FR. Catheter Length: 15cm. * Dilator Diameter: 58 FR. * Dilator Length: 70 CM. * Disposable Single Use Only * Rx Only * 2008/05 * Cook * Wilson Cook Medical GI Endoscopy * 4900 Bethania Station Road, Winston Salem, NC 27105

    FDA Recall
    Terminated ·Cook Endoscopy·Product code KOG·April 20, 2006

    Codman External Drainage System 3 (EDS 3) CSF Without Ventricular Catheter Catalog Number: 82-1731

    FDA Recall
    Terminated ·Codman & Shurtleff, Inc.·August 4, 2006

    The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.

    FDA Recall
    Open, Classified ·Vision RT Ltd Dove House Arcadia Avenue London United Kingdom·Product code IWE·August 27, 2025

    Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.

    FDA Recall
    Terminated ·Ceg Enterprises Llc·Product code MCF·April 5, 2016

    X-Cel MB-700 A/C Podiatry X-Ray System; X-Cel X-Ray Coporation, 4220 Waller Drive, Crystal Lake, IL 60012

    FDA Recall
    Terminated ·X-Cel X-Ray Corp·Product code KPR--·November 12, 2002

    Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION TRAY, Model Number: MNS13635A; 2) C-SECTION PCH-LF, Model Number: DYNJ81281; 3) C-SECTION PACK-LF, Model Number: OBK387M; 4) C-SECTION PCH-LF, Model Number: DYNJ81281; 5) NHS - C-SECTION SCG, Model Number: DYNJ40573A; 6) C-SECTION CDS, Model Number: CDS983998C; 7) C-SECTION ADD ON PACK, Model Number: DYNJ64300A; 8) EMERGENCY BIRTH PACK, Model Number: DYNJ55205; 9) C-SECTION PACK, Model Number: DYNJ56550; 10) C-SECTION ADD ON PACK, Model Number: DYNJ83507; 11) C-SECTION CLOSURE PACK, Model Number: DYNJ83248; 12) C-SECTION PCH-LF, Model Number: DYNJ81281

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OHM·March 3, 2025

    Medline Convenience kits labeled as: 1) PREP TRAY, Pack Number DYNDA1540; 2) STERILE PREP TRAY , Pack Number DYNDA2499; 3) ED PREP TRAY, Pack Number DYNDA2519; 4) ED PREP TRAY, Pack Number DYNDA2519H ; 5) PRE-OP PREP KIT , Pack Number DYNDA3076; 6) PILGRIM PREP TRAY , Pack Number DYNDC3282; 7) PILGRIM PREP TRAY , Pack Number DYNDC3282A ; 8) PILGRIM PREP TRAY , Pack Number DYNDC3282B ; 9) KYPHO PREP PACK-LF, Pack Number DYNJ0618280G ; 10) KYPHO PREP PACK-LF, Pack Number DYNJ0618280I ; 11) KYPHO PREP PACK-LF, Pack Number DYNJ0618280J ; 12) SPECIAL PROCEDURE PREP TRAY-LF, Pack Number DYNJ0738967A ; 13) BASIC SET UP PACK-LF, Pack Number DYNJ28988I ; 14) BASIC SET UP PACK-LF , Pack Number DYNJ28988I ; 15) VERTEBRALPLASTY PREP TRAY PACK, Pack Number DYNJ36311A ; 16) PK-SETUP PACK , Pack Number DYNJ43804A ; 17) SKIN LESION PACK, Pack Number DYNJ44258G ; 18) SETUP PACK, Pack Number DYNJ46187D ; 19) PK-SET UP -LF , Pack Number DYNJ53220B ; 20) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857A ; 21) SKIN SCRUB PACK , Pack Number DYNJ68561; 22) DMEK PREP PACK, Pack Number DYNJ81659A ; 23) SET UP PACK , Pack Number DYNJ84247; 24) BASIC SET UP PACK-LF, Pack Number DYNJ85036; 25) SET UP CDS-ASC, Pack Number DYNJ900073C; 26) GENERAL SET UP, Pack Number DYNJ906282C; 27) JEWISH MAJOR SETUP, Pack Number DYNJ909261A; 28) SET UP, Pack Number DYNJ909403 ; 29) PREP TRAY , Pack Number DYNJRA1280A; 30) PREP TRAY , Pack Number DYNJRA1424 ; 31) NERVE BLOCK/W , Pack Number DYNJRA1424H; 32) PREP TRAY, Pack Number DYNJRA1498B; 33) PREP TRAY , Pack Number DYNJRA1583C; 34) PREP TRAY , Pack Number DYNJRA1760 ; 35) PREP TRAY , Pack Number DYNJRA1774 ; 36) PREP TRAY , Pack Number DYNJRA1783 ; 37) PREP TRAY , Pack Number DYNJRA1946A; 38) WINCHESTER PREP PACK-LF , Pack Number PHS627837003 ; 39) WINCHESTER PREP PACK-LF , Pack Number PHS627837003A

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OJU·April 8, 2024

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Recall
    Terminated ·CHG Hospital Beds Inc 153 Towerline Place London Canada·Product code FNL·June 28, 2016

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Recall
    Terminated ·CHG Hospital Beds Inc 153 Towerline Place London Canada·Product code FNL·February 18, 2015

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Recall
    Terminated ·CHG Hospital Beds Inc 153 Towerline Place London Canada·Product code FNL·June 28, 2016

    Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measurement of Vitamin B12 in human serum and plasma.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDD·May 8, 2012

    IMx Free T4 Reagent Kit, list 2222-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD·Product code CEC·May 30, 2003

    Access Free T4 Calibrator, Part Number: 33885, Lot Numbers: 014769 The Access Free T4 Calibrators are intended to calibrate the Access Free T4 assay for the quantitative determination of free thyroxine levels in human serum and plasma (heparin) using the Access Immunoassay Systems

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CEC·November 11, 2010

    Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia Vaporizer

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CAD·April 21, 2016

    IMMULITE /IMMULITE 1000 Vitamin B12

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CDD·January 2, 2018

    FastPack Free T4 Immunoassay Chemilunescence assay for the determination of Free T4 The FastPack free T4 Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of FT4 in human serum. The FastPack free T4 Immunoassay is designed for use with the FastPack System.

    FDA Recall
    Terminated ·Qualigen Inc·Product code CEC·November 8, 2013

    Dimension Free Thyroxine (FT4L) Flex reagent cartridge

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code CEC·January 2, 2018

    Alinity i Free T4 Reagent Kit, List Number 07P7030

    FDA Recall
    Terminated ·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code CEC·November 21, 2018