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    Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code JEA·September 19, 2024

    Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code JEA·September 19, 2024

    Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code JEA·September 19, 2024

    Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code JEA·September 19, 2024

    Non-continuous ventilator accessories under the following brand names: a) Adult ECG Electrodes model number 1016360; b) O2 Enrichment Attachment BX 10 model number 312010; c) O2 Enrichment Attachment Single model number 312710; d) Alice 5, Domestic model number 1017226; e) BIPAP Auto M.W/Humid, W/SmartCard, CA model number CA701HS; f) BIPAP Auto M.W/Humid, W/SmartCard, US model number DS700HS; g) BIPAP Auto M, W/SmartCard, US model number DS700S; h) BIPAP Auto SV W/SmartCard Dom Core model number 1040716; i) BIPAP Harmony, Intl model number 1012823; j) BIPAP Plus M, US model number DS600; k) BIPAP Plus M, W/Humid US model number DS600H; l) BIPAP S/T Core Pkg NA model number 1014248; m) BIPAP S/T North America model number 1012885; n) BIPAP Vision Filter Pack model number 582101; o) Duet LX/BIPAP Pro/Synch Pollen QTY 1 model number 1039611; p) FLXTB, 5 inch STD, 22 mm, CE model number 1006042; q) FLXTB, 6 in Trach 15 mm taper, CE model number 1004968; r) GP UL-Fine Filter 2 pack model number 1006190; s) Incoming Filter 7000, 7001 CPAP model number 7070; and t) Infant ECG Electrodes model number 1016361. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.

    FDA Recall
    Terminated ·Respironics, Inc.·Product code GWQ·October 15, 2007

    Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331

    FDA Recall
    Open, Classified ·Zoe Medical Incorporated·Product code DQA·August 13, 2024

    EasyOne Pro Respiratory Analysis System Pulmonary Function Testing Device, Model 3000-1

    FDA Recall
    Terminated ·NDDd Medical Technologies, Inc.·Product code BTY·August 15, 2017

    EasyOne Pro LAB VOS Respiratory Analysis System Pulmonary Function Testing Device, Model 3100-1

    FDA Recall
    Terminated ·NDDd Medical Technologies, Inc.·Product code BTY·August 15, 2017

    Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70025-02 Expiration 2012-02, Sterilized with Ethylene Oxide , Cardiovascular Systems, Inc., St. Paul, MN USA. The Diamondback 360 OAD are used with CSI's orbital atherectomy system in patients with arterial disease.

    FDA Recall
    Terminated ·Cardiovascular Systems, Inc.·Product code MCW·April 16, 2009

    Tecan clinical workstation; 10-415 Tecan Genesis 150 front end, Roche catalog number 03585379001.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code JQW·May 5, 2004

    Elana Catheter Sizer 2.0*** The Elana Catheter Sizer 2.0 is designed to aid the surgeon to assess the bypass graft of the ELANA technique.

    FDA Recall
    Terminated ·Elana, Inc.·Product code MCW·February 14, 2013

    Peripheral Diamondback 1.50 Solid OAD, a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.

    FDA Recall
    Terminated ·Cardiovascular Systems Inc·Product code MCW·September 14, 2017

    HAMILTON HEATER SHAKER, 115 VAC/ 230 VAC, 750 VA, Power Consumption 41V/ 100W (max.), Relative Humidity 15% - 85% no condensation. REF 19903400

    FDA Recall
    Open, Classified ·Hamilton Co·Product code JQW·January 15, 2021

    The product is a stainless steel stent mounted on a PTA balloon delivery device. The product is indicated for the palliation of malignant neoplasms in the biliary tree. The product is labeled as Edwards Lifesciences, LifeStent LP SDS, Biliary Endoprosthesis. Manufactured by ORBUS, MEDICAL TECHNOLOGIES. 5363 NW 35th Ave, Fort Lauderdale, FL, 33309. Ph 954 730-071, www. orbus.com. Distributed by: Edwards Lifesciences, Irvine, CA 82014-5888. Ref. Baloon-Expandable Stent and delivery System. Catalog Numbers SD186U14D SD186U24D SD366U14D SD366U24D

    FDA Recall
    Terminated ·Orbus Medical Technologies Inc·Product code MEW·March 19, 2004

    COULTER PrepPlus, Part Number: 286600

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code JQW·January 21, 2010

    Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower.

    FDA Recall
    Terminated ·Tecan U S Inc·Product code JQW·February 27, 2003

    Microlab F.A.M.E. reagent containers, Part number 148482, box containing 48 containers each. For in vitro diagnostic use.

    FDA Recall
    Terminated ·Hamilton Co·Product code JQW·March 29, 2007

    Syringe, 62RNR 2.5 Microliter Syringe, with needle point style 3 (blunt needle point for use with HPLC injection valves and for sample pipetting) Part #: 87942.

    FDA Recall
    Terminated ·Hamilton Co·Product code JQW·March 28, 2006

    SilverHawk Peripheral Cutter Driver Plaque Excision System REF Catalog No: FG 02550, Sterilized with gamma radiation, Manufacturer ev3 Inc. 4600 Nathan Lane North, Plymouth, MN 55442, Manufactured at : 9775 Toledo Way, Irvine, CA 92618., Intended for use in atherectomy of the peripheral vasculature. The catheter is NOT intended for use in the coronary or carotid vasculature.

    FDA Recall
    Terminated ·Product code MCW·January 21, 2010

    CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003. The Diamondback 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.

    FDA Recall
    Terminated ·Cardiovascular Systems, Inc.·Product code MCW·May 23, 2014