BEUDAMED
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    XVIVO Organ Chamber REF 19020

    FDA Recall
    Terminated ·XVIVO PERFUSION AB Massans Gata 10 Goteborg Sweden·Product code PHO·April 8, 2022

    Elan Diagnostics CHO ATAC Cholesterol Reagent Kit Product Number: 516-250

    FDA Recall
    Terminated ·Elan Diagnostics, Inc.·Product code CHH·November 7, 2002

    CORAIL AMT HIGH OFFSET NECK SEGMENT (KHO), Pro. Code L20433 Product Usage: The affected CORAIL Neck Trials are surgical instruments used in CORAIL total and partial hip arthroplasty.

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code LXH·September 21, 2018

    GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code BSZ·August 30, 2010

    GE Datex-Ohmeda Avance Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code BSZ·August 30, 2010

    GE Datex-Ohmeda Amingo Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code BSZ·August 30, 2010

    Signa Excite" 1.5 T Magnetic Resonance Systems, manufactured by GE Healthcare, P.O. Box 44 Milwaukee, WI 53201.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code LNH·May 11, 2009

    PRO-DEX Surgical Driver Battery Pack PDBP-001 Series PRO-DEX Battery Pack, Single Pouch - PDBP-001-2 PRO-DEX Battery Pack, 40 Pouches - PDBP-040-2 Product Usage: -The PDBP-001 Battery is a single use (non-rechargeable) sterile lithium ion battery accessory that powers the PDSD Surgical driver. There is only one PDSD Surgical driver currently being produced (PDSD-5000) and the battery only works to power this driver. -The PDSD Series surgical drivers are Pro-Dex Branded surgical fixation drivers meant to drive surgical screws into bone in the CMF region of the body. They are class I exempt (Product codes GEY/GXL) battery powered hand pieces with a fixed collet. The only accessory is the PDBP-001 battery.

    FDA Recall
    Terminated ·Pro-Dex Inc·Product code GEY·September 25, 2018

    Battery Pack KLS-SD-1000 Case (40 ct) Models: KLS-BP-040 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    FDA Recall
    Terminated ·Pro-Dex Inc·Product code MOQ·December 23, 2015

    Battery Pack KLS-SD-1000 Single Models: KLS-BP-001 Used to power the KLS Martin Max Driver (battery powdered surgical screwdriver).

    FDA Recall
    Terminated ·Pro-Dex Inc·Product code MOQ·December 23, 2015

    Diamond Mammographic X-Ray System, type MGX-2000, model 5111771. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201 U.S.A.

    FDA Recall
    Terminated ·General Electric Med Systems LLC·Product code IZH·November 16, 2005

    GE LOGIQ 3 Expert ultrasound scanner with software versions 4.0.5, 4.1.1 and 4.1.2. GE Healthcare P.O. Box 414, Milwaukee, Wisconsin 53201

    FDA Recall
    Terminated ·GE Healthcare Clinical Systems·Product code IYN·September 4, 2007

    Precision Ice One-Patient-Use Control Unit and Wrap System (Model # 4BB02BK). The device is intended to reduce edema and promote healing of soft-tissue injuries and lymphedema through stimulation of the lymphatic system. The device is a therapeutic system which consists of a control unit and fluid circulating pads. The pads are mounted in wraps designed for specific parts of the body such as ankle, knee, elbow, and shoulder. The pads provide cold treatment and pressure which help promote healing. The owner's manual is labeled in part: "PRO TRAINERS' CHOICE COMPANY, INC.***www.precisionice.com***[email protected]***Mailing Address PO Box 27***Kingston, WA 98346 USA***Phone: 360-297-3902***Shipping Address***26129 Calvary Lane NE, Suite 200***Kingston, WA 98346 USA***Fax: 360-297-3903". The sticker which is placed on the back of the control board is labeled in part: "MOD#4BB02BK***SER#100***". The shipping box is labeled in part: "Pro Trainers' Choice' LLC***Model #4BB02BK***Serial #100____***". The knee wrap is labeled in part: "***Pro Trainers' Choice Co. Inc./Precision Ice One Patient Use Knee Wrap***#1BK01051KN***This device is to be used for one patient only; do not re-use!***".

    FDA Recall
    Terminated ·Pro Trainers' Choice Company·Product code ILO·April 18, 2011

    Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA

    FDA Recall
    Terminated ·Biomet, Inc.·Product code JWH·July 1, 2014

    ThermaCare Menstrual 8 Hour Heat Wraps, 3 count, NDC 0573-3020-02, SKU: 302002, UPC: 3-0573-3020-02-9, Wyeth Consumer Healthcare, P.O. Box 26609, Richmond, VA 23261-6609

    FDA Recall
    Terminated ·Pfizer Global·Product code IMD·September 24, 2010

    Weck, Endo5, Hem-o-lok ML, Ref 544965, Hem-o-lok ML Endoscopic Clip Applier, Non-Sterile Clean and sterilize before use. Weck Closure Systems, TFX Medical Ltd., Halifax Road, P.O. Box 138, High Wycombe HP123NB U.K.

    FDA Recall
    Terminated ·Product code GDO·October 31, 2001

    product labeled in part: ''***banicide ADVANCED, A Reusable Sterilizing & Disinfecting Solution***Active Ingredient: Glutaraldehyde (1,5 Pentanedial) 3.5%***NET CONTENTS: 3.8l (ONE U.S. GALLON)***Manufactured by Pascal Company, Inc. 2929 N.E. Northup Way P.O. Box 1478 Bellevue, WA 98009-1478 USA***''

    FDA Recall
    Terminated ·Pascal Co Inc·Product code MED·August 9, 2005

    Kotex Natural Balance Security tampons, regular absorbency, unscented. packaged in 18 count or 36 count retail containers. Consumer Services, Kimberly-Clark Corp. Dept. KNBTR-18, P.O. Box 2020, Neenah, WI 54957-2020 USA. To absorb menstrual or other vaginal discharge.

    FDA Recall
    Terminated ·Kimberly-Clark Corporation·Product code HEB·November 3, 2011

    Device Brand Name: Distal Radius Fracture Repair System Device Classification Name: Plate, Fixation, Bone Device Common Name: Drill Guide DNP 3.3mm Labeling: DRILL GUIDE DNP 3.3 MM NON-STERILE LOT NB0311 QTY 1 DePuy P.O Box 988 Warsaw IN 46581

    FDA Recall
    Terminated ·Biomet, Inc.·Product code HRS·June 23, 2014

    DiaSorin ETI-EBNA-G kits, Catalog No. P001607A. In vitro diagnostic. For the qualitative and/or semi-quantitative detection of IgG antibody to Epstein-Barr Nuclear Antigen in human serum. Diasorin Inc. 1951 Northwestern Avenue P.O. Box 285, Stillwater, MN 55082-0285

    FDA Recall
    Terminated ·Diasorin Inc.·Product code LLM·March 14, 2007