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    0.10% BreathScan Alcohol Detector manufactured for WNCK, Inc., The Woodlands, TX by Howard Industries, Inc., Columbus, OH (crystals) and James Alexander Corp., Blairstown, NJ (general device assembly). Product sold in bulk and individually packaged. Bulk product (500-1000 units) distributed in unlabeled clear plastic bags. Individually packaged product packaged and sealed in clear plastic bags with labeling and sold in boxes containing 100 units/box.

    FDA Recall
    Terminated ·WNCK, Inc·Product code DJZ·November 30, 2005

    Integra Ojemann Cortical Stimulator; Product / Catalogue No: OCS2. Intended for intraoperative cortical stimulation mapping procedures.

    FDA Recall
    Terminated ·Integra Burlington MA, Inc.·Product code GYC·March 18, 2013

    PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered

    FDA Recall
    Terminated ·Handicare Usa Inc·Product code FSA·September 8, 2017

    Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4) CYSTO PACK, REF DYNJ35569C; 5) PAVILION MINOR PACK, REF DYNJ40724D; 6) CYSTOSCOPY PACK, REF DYNJ41105C; 7) MINOR PACK, REF DYNJ42132A; 8) RECTAL PRONE PACK, REF DYNJ43380A; 9) HERNIA APPENDECTOMY TEGH-LF, REF DYNJ46716; 10) CYSTO PACK, REF DYNJ47821F; 11) CYSTO PACK, REF DYNJ48978C; 12) CYSTO PACK, REF DYNJ50428C; 13) MID HUDSON CYSTO PACK, REF DYNJ53418B; 14) CYSTO PACK-LF, REF DYNJ55479D; 15) CYSTO PACK, REF DYNJ58445A; 16) MINOR PACK, REF DYNJ58566B; 17) CSTM PK GEN NEW ENGL SURG, REF DYNJ59431; 18) RIDGEWOOD LAP PACK-LF, REF DYNJ60077A; 19) FLEXIBLE CYS PACK, REF DYNJ62111C; 20) CYSTO PACK, REF DYNJ65830A; 21) MAIN & ODS CYSTO PACK, REF DYNJ66821A; 22) PROCEDURE CYSTO PACK, REF DYNJ68883; 23) CYSTO PACK, REF DYNJ69729; 24) MINOR SURGERY PACK, REF DYNJ80004; 25) LAPAROSCOPY PACK, REF DYNJ80763; 26) LAPAROSCOPY PACK, REF DYNJ80763; 27) CYSTO PACK, REF DYNJ82626; 28) MINOR PACK, REF DYNJ83155; 29) SY CYSTO, REF DYNJ900583M; 30) CYSTO, REF DYNJ905569B; 31) CYSTO, REF DYNJ907541A; 32) SET UP PACK-LF, REF LLSCASET01; 33) MAJOR PACK, REF SYNJ910011B

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code FDE·September 4, 2024

    Siemens Mevatron Linear Accelerator Systems: KD2, K 7767, K 8067, KD, KDS and KDS2, Mevatron KD2, Part No.: 1940753; Mevatron KD2, Part No.: 08515520; Mevatron KD2-Part No.: 9822685; Mevatron K 7767, Part No.: 5694302; Mevatron K 8067, Part No.: 5694401; Mevatron KD, Part No.: 8319857; Mevatron KDS, Part No.: 9401522; Mevatron KDS2, Part No.: 9411588; and Mevatron KDS2, Part No.: 9822693, Siemens Medical Solutions USA, Inc., Concord, CA

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·July 27, 2007

    Siemens Mevatron KDS-2 Medical Charged-Particle Radiation Therapy System; (Interlock #51 Jaw Field Position) Model Number 9822693 and 9411588, Siemens Medical Solutions, Concord, CA 94520

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·August 7, 2007

    MEVATRON KDS,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401522, MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·March 22, 2007

    Mevatron KDS-2 Medical Linear Accelerator, Material Number: 9822693, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·January 11, 2008

    Mevatron KDS-2 Medical Linear Accelerator, Material Number: 09822685, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·January 11, 2008

    Mevatron KDS-2 Medical Linear Accelerator, Material Number: 09411588, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·January 11, 2008

    Mevatron KDS-2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·December 1, 2011

    MEVATRON KDS-2,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBERS: 9411588 and 9822693,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·March 22, 2007

    Mevatron KDS-2; Siemens Healthcare Concord, CA 94520 Product Usage: PRIMUS and MEVATRON Linear Accelerators are intended to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·December 1, 2011

    Siemens Medical Solutions, Mevatron KDS-2 Digital Linear Accelerator, part number 9411588 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV. Medical charged-particle radiation therapy system.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·December 10, 2007

    Siemens Medical Solutions, Mevatron KDS-2 Digital Linear Accelerator, part number 9822693 equipped with a Digital Electron Variable Applicator (DEVA, Part Number 8485971) with available energy of 6 MeV. Medical charged-particle radiation therapy system.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·December 10, 2007

    LINAC Accelerators: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIMUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON KDS-2, MEVATRON KD-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON M2 6300, MEVATRON MDX-2, MEVATRON MD-2; The intended use of the MEVATRON, PRIMUS, ONCOR and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. Product Usage: The intended use of the MEVATRON, PRIMUS, ONCOR and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·December 19, 2014

    Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON 6300, MEVATRON MDX-2, MEVATRON MD-2, MEVATRON KD, MEVATRON KDS, MEVATRON 77, MEVATRON K7467, MEVATRON 7767, MEVATRON K8067, MEVATRON M 6300 (MX), MEVATRON M 6730, MEVATRON M 7140, MEVATRON M 7400, MEVATRON MDX, MEVATRON MD (MD, MDX), MEVATRON M 7445 (MXE), MEVATRON M 7400/7440 (MXE), MEVATRON M 6730/6740 (MXE), MEVATRON M 6700 (MX): the intended use of the MEVATRON , PRIMUS , ONCOR and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·December 2, 2014

    Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code KHS·April 5, 2023

    Brand Name: Q-Stop Product Name: Suture Retention Device Model/Catalog Number: QS Software Version: N/A Product Description: The DRS Vascular Q-Stop Suture Retention Appliance is a sterile, single-use, lightweight device made of biocompatible materials that can be easily installed within minutes to assist with venous access hemostasis. Component: No

    FDA Recall
    Open, Classified ·Drs Vascular, Inc·Product code KGS·May 16, 2025

    BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the quantitative determination of Bicarbonate in human serum and plasma on Beckman Coulter AU analyzers.

    FDA Recall
    Open, Classified ·Beckman Coulter Ireland, Inc. Lismeehan O'Callaghan'S Mills Ireland·Product code KHS·October 14, 2025