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    Arm and Hammer Spinbrush Dual Action Powered Toothbrush Spinbrush Pro Whitening Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.

    FDA Recall
    Terminated ·Church & Dwight Inc·Product code JEQ·December 22, 2011

    Pilling Center-Action Forceps with Insulated Shafts- Elongated Cup Biopsy Jaws, Catalog Number: 505039, Non Sterile, Rx Only, (30 CM), Manufactured for: Teleflex Medical, Research Triangle Park, NC 27709 USA

    FDA Recall
    Terminated ·Telefelx Medical·Product code HTD·October 31, 2007

    Pilling Center-Action Forceps with Insulated Shafts- Circular Cup Biopsy Jaws, Catalog Number: 505045, Non Sterile, Rx Only, (30 CM), Manufactured for: Teleflex Medical, Research Triangle Park, NC 27709 USA

    FDA Recall
    Terminated ·Telefelx Medical·Product code HTD·October 31, 2007

    Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.

    FDA Recall
    Terminated ·Church & Dwight Inc·Product code JEQ·December 22, 2011

    Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various models. Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.

    FDA Recall
    Terminated ·Church & Dwight Inc·Product code JEQ·December 22, 2011

    Pilling Center-Action Forceps with Insulated Shafts- Serrated Grasping Jaws, Catalog Number: 505015, Non Sterile, Rx Only, (ALLIG GRASPING FCPS 30 CM INSUL), Manufactured for : Teleflex Medical, Research Triangle Park, NC 27709 USA

    FDA Recall
    Terminated ·Telefelx Medical·Product code HTD·October 31, 2007

    Phantom-brand Black Latex Powder Free Examination Gloves, 100 gloves by weight, size small and Medium, Product Code PHM912, Lot No. 002-E1LF302-1, Manufacture date JUL 2011, Size Small Product Code PHM915, Lot No. 002-E1LF305-1, Manufacture date JUL 2011, Size Medium Examination Disposable Gloves

    FDA Recall
    Terminated ·Adenna Inc·Product code LYY·December 22, 2011

    Mindray V12 Size: 320 mm X 320 mm X 450 mm N.W.: 3 kg G.W.: 6 kg Qty:1 Manufactured in China Mindray V21 Size: 515 mm X 335 mm X 685 mm N.W.: 8 kg G.W.: 11 kg Qty:1 Manufactured in China One product, V Series monitor, available in two sizes: The V12 has a 12 inch screen, the V21 has a 21 inch screen. The V Series Monitor is a Multi Parameter Patient Monitor (with Arrhythmia Detection and Alarms) capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. It also monitors of the following human physiological parameters: 1) ECG waveform derived from 3, 5, 6 and 12 lead measurements, 2) Heart Rate, 3) Pulse Oximetry (Sp O2), 4) ST Segment Analysis, 5) Arrhythmia Detection, 6) Non Invasive Blood Pressure (NIBP), 7) Invasive Blood Pressure (IBP), 8) Cardiac Output (CO), 9) Respiratory Gasses, 10) Respiration Rate, 11) Temperature, It is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner.

    FDA Recall
    Terminated ·Mindray DS USA, Inc. d.b.a. Mindray North America·Product code MHX·September 24, 2012

    SEQUENCER component of MOSAIQ versions 1.30 (all builds), 1.40 (all builds), 1.50 (all builds), 1.60 (all builds), and 2.0 (all builds). Manufactured by IMPAC Medical Systems, Inc. Sunnyvale, CA. The intended use of SEQUENCER (a verification system) is to assist in the process of patient treatment on a radiotherapy treatment machine. SEQUENCER provides the capability to notify the users of actions that need to take place prior to treatment, to display reference images for set up purposes, and to auto setup the machine to predefined settings. Actual settings are read from the treatment machine, via the machine's communication interface, and compared to the predefined values. If a mismatch occurs between the planned values and the actual machine settings, treatment is prohibited. At appropriate times during the treatment, the actual delivered values are recorded to provide treatment tracking. Treatments are initiated by the operator, via the machine control system, only after the user has verified that the treatment setup is correct. SEQUENCER does not bypass any checks put in place by the machine's control system.

    FDA Recall
    Terminated ·Impac Medical Systems Inc·Product code IYE·July 17, 2009

    VERSYS HIP SYSTEM FEMORAL HEAD 12/14 TAPER 28 MM DIA. -3.5 MM NECK LENGTH ZIMALOY CO-CR-MO ALLOY STERILE QTY-1 MANUFACTURED BY ZIMMER MANUFACTURING B.V., A SUBSIDIARY OF ZIMMER, INC. (WARSAW, IN) The VerSys Hip System Femoral Heads are intended for use in total hip arthroplasty and are assembled onto the proximal taper of the hip stem. The femoral heads manufactured from Zimaloy Alloy are intended for mating with Tivanium" Ti-6AL-4V Alloy and Zimaloy Alloy femoral stems equipped with taper necks. These femoral heads are available in two Morse-type taper options, 6-degree and 12/14, each of which mates with the corresponding 6 degree or 12/14 taper of a femoral stem prosthesis. Each taper option is supplied in a variety of diameters and neck lengths for use in total hip arthroplasty.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code LPH·July 5, 2010

    VERSYS HIP SYSTEM FEMORAL HEAD 12/14 TAPER 32 MM DIA. -3.5 MM NECK LENGTH ZIMALOY CO-CR-MO ALLOY STERILE QTY-1 MANUFACTURED BY ZIMMER MANUFACTURING B.V., A SUBSIDIARY OF ZIMMER, INC. (WARSAW, IN) The VerSys Hip System Femoral Heads are intended for use in total hip arthroplasty and are assembled onto the proximal taper of the hip stem. The femoral heads manufactured from Zimaloy Alloy are intended for mating with Tivanium" Ti-6AL-4V Alloy and Zimaloy Alloy femoral stems equipped with taper necks. These femoral heads are available in two Morse-type taper options, 6-degree and 12/14, each of which mates with the corresponding 6 degree or 12/14 taper of a femoral stem prosthesis. Each taper option is supplied in a variety of diameters and neck lengths for use in total hip arthroplasty.

    FDA Recall
    Terminated ·Zimmer Inc.·Product code LPH·July 5, 2010

    Stryker Wire Caddy, Stryker Instruments Wire Caddy, REF 505-505, STERILE, QTY 1, MANUFACTURED FOR STRYKER INSTRUMENTS, KALAMAZOO, MI USA 49001 (269) 323-7700 (800) 253-3210. This device is intended for use in the storage and retrieval of guide wires up to 9.8 ft. in length and recommended for guide wires of .018 to .038 inches in diameter.

    FDA Recall
    Terminated ·Stryker Instruments Division of Stryker Corporation·Product code MDM·May 27, 2011

    VITROS Chemistry Products Calibrator Kit 2, manufactured by Ortho Clinical Diagnostics 1000 Lee Road Rochester, NY 14606 VITROS Chemistry Products Calibrator Kit 2 is used to calibrate VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System for the quantitative measurement of CHOL, Cl-, ECO2, K+, Na+, and TRIG.

    FDA Recall
    Terminated ·Ortho-Clinical Diagnostics·Product code JIX·October 17, 2013

    FMI 105"Oral Surgery Administration Set; Item AMS-468-1 Manufactured For: First Medical inc., 8515 Douglas Ave., Suite 23 Urbandale, IA 50322 Intended use: Intravascular Administration Set

    FDA Recall
    Terminated ·Churchill Medical Systems, Inc.·Product code FPA·November 16, 2010

    Viterion 100-BGM TeleHealth Monitor, Model No. 09377512, Product Code/Part No. 81842478, Bayer HealthCare LLC 555 White Plains Road, Tarrytown, NY 10591-5097 USA --- Manufactured in Japan for Bayer HealthCare LLC -- Common Name: Viterion100 TeleHealth Monitor -- Classification Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) [ref. 21CFR 870.2300] Product Usage: The Viterion 100 TeleHealth Monitor and related Data Server are physiological monitoring systems. The systems collect, accumulate and periodically transmit patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner, and provides communication between the patient and the practitioner. The physiological monitoring instrument, selected by the healthcare practitioner, operates in conjunction with the Patient Terminal located in the patients home, a hospital room, nursing home, or other healthcare facility. The Patient Terminal connects to the server via a conventional or cellular telephone line. The system is not a real-time monitoring system, and there is no requirement that a health care professional review the information at any specific interval or provide immediate feedback to patients. Rather, the system is intended to aid the physicians longer term management of patients. Patients are expected to take the same short term actions in response to physiological data as they ordinarily would in the absence of the Tele Health Monitor.

    FDA Recall
    Terminated ·Viterion TeleHealthcare Llc·Product code MWI·May 25, 2011

    KING SYSTEMS, A Consort Medical Company, KLTD212, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 2, Manufacturer: King Systems Corporation, 15011 Herriman Boulevard, Noblesville, IN 46060, 317-776-6823, Made in the U.S.A. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·January 14, 2011

    Safety glasses made with "Rage" frames manufactured between February 20, 2014 and February 25, 2014. The color of the frames of the recalled glasses were either white or black. Safety Eye wear

    FDA Recall
    Terminated ·Wal Mart Stores, Inc·Product code HQG·February 26, 2014

    Sterile sterile surgical kits containing Episeal products, packaged as follows: DeRoyal CLINIC PICC KIT, REF 47-483, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal PICC DRESSING CHANGE KIT, REF 47-491.12, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal PICC KIT-NICU, REF 47-626.10, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal ST CENTRAL LN DRUG CHG KIT, REF 47-732.03, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal NICU PICC LINE KIT, REF 47-787.00, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal ORAL IMPLANT TRAY, REF 50-7104.05, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal A-LINE/CENTRAL LINE PLACEMENT, REF 50-7195.12, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal STEREO BREAST BIOPSY TRAY, REF 50-9786.03, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal BASIC BIOPSY TRAY, REF 50-12421.10, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal LAP CHOLE TRAY, REF 50-12892.09, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal KNEE ARTHROSCOPY TRAY, REF 50-12898.07, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal NEURO SPINE PACK, REF 50-13252.09, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal BREAST BIOPSY TRAY, REF 70-10770.05, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal ANGIOGRAM TRAY-4/CASE, REF 70-1911.20, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal DIAGNOSTIC LAP BASIN, REF 89-0323.06, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal PLASTICS TRAY, REF 89-1918.07, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal LAP TUBAL VALUE SET, REF 89-2176.09, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal PACEMAKER TRAY, REF 89-2703.08, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal LAP GYN, REF 89-2995.10, STERILE EO, Rx Only, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal EXTREMITY TRAY, REF 89-3053.11 and 89-3053.10, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal SHOULDER ARTHROSCOPY TRAY, REF 89-3190.10, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal ENT EAR TRAY, REF 89-3338.11, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal CHILD CENTRAL LINE, REF 89-3351.07, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal SHUNT TRAY, REF 89-3452.07, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal LAMI/DISC PACK, REF 89-3472.08, STERILE EO, Rx Only, Manufactured by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal LAPAROTOMY TRAY, REF 89-3482.06, STERILE EO, Rx Only, Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal MINOR INTERVENTIO

    FDA Recall
    Terminated ·Deroyal Industries, Inc. Lafollette·Product code KDD·February 7, 2012

    Penner Manufacturing Transfer Electric Pacific Chair, Patient Transfer/Lift System, Models 393000-1. The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.

    FDA Recall
    Terminated ·Penner Mfg Inc·Product code FNG·January 19, 2009

    SoftLab/Mic ASCII Add-on Versions 4.0.1.14, 4.0.1.15, and 4.0.1.16. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760. Version 4.0.1.14 Manufactured & Distributed 12/29/2006. Version 4.0.1.15 Manufactured & Distributed 05/02/2007. Version 4.0.1.16 Manufactured & Distributed 08/22/2008. Used in a medical research or clinical laboratory setting by knowledgeable, trained and experienced personnel.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code JQP·February 16, 2010