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    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Console 2i REF 450-0005-01 -Power Control Console 2i REF ECOS-450-0005-00 OsteoMed Footswitches: -OsteoMed BMF Footswitch REF 450-0390 -D-Bi-Directional Master Footswitch REF 450-0380 -D-Uni-Directional Footswitch II REF 450-0350 -D-Bi-Directional Footswitch II REF 450-0360 -D-Uni-Directional Master Footswitch REF 450-0370

    FDA Recall
    Open, Classified ·Osteomed, LLC·Product code KMW·October 28, 2021

    ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.

    FDA Recall
    Terminated ·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code CDP·October 12, 2018

    ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.

    FDA Recall
    Terminated ·Abbott Ireland Diagnostics Division Lisnamuck Co. Longford Ireland·Product code CDP·October 12, 2018

    Tina-quant Complement C4 ver.2, Catalog 05991994190

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code DBI·August 27, 2020

    C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 604 nm, which correlates with the concentration of C4 in the sample.

    FDA Recall
    Terminated ·Abbott Laboratories, Inc·Product code DBI·May 16, 2018

    Medfusion Model 4000 Syringe Infusion Pump, with PharmGuard Server Software (PGS). Sold under the following names: MEDFUSION 4000 Pump V1.0; MEDFUSION 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION 4000 Pump V1.5, V1.5.1; MEDFUSION 4000 Pump V1.5, V1.5.1; MEDFUSION 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code LKK·October 15, 2018

    Medfusion Syringe Pump 4000 Series The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of the syringe infusion pump can be monitored or supervised by a clinician; 5) Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code FRN·November 13, 2017

    Medfusion Syringe Pump 3500 Series The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of the syringe infusion pump can be monitored or supervised by a clinician; 5) Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code FRN·November 13, 2017

    Medfusion Syringe Pump 3010 Series The Medfusion Syringe Infusion Pumps are indicated for the following uses: 1) Administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2) By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3)By the following delivery modes: continuous, volume/time, mass, body weight, intermittent, and bolus; 4) In critical care, anesthesia, neonatal, and pediatric applications or other healthcare settings where use of the syringe infusion pump can be monitored or supervised by a clinician; 5) Inside the MRI room mounted outside the 150 Gauss line and with shielded magnets of field strength of 1.5 Tesla.

    FDA Recall
    Terminated ·Smiths Medical ASD Inc.·Product code FRN·November 13, 2017

    Profile 8 x 20 mm Cannulated Interference Screw Round Head Catalog Number: 230420

    FDA Recall
    Terminated ·Mitek Worldwide·June 16, 2003

    Profile 7 x 25 mm Cannulated Interference Screw Round Head Catalog Number: 230325

    FDA Recall
    Terminated ·Mitek Worldwide·June 16, 2003

    Satellite Spinal System Primary User Group Reference Guide, 8 1/2 by 11 inch plastic binder, Medtronic Sofamor Danek, Medtronic, Memphis, TN 38132

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy, (1 x 15 cm) Rx only, Latex Free; Sterile Health Industry Bar Code: H984BWS4464509A. Packaged in boxes of 15 units per box.

    FDA Recall
    Terminated ·ConvaTec·Product code OMP·July 13, 2009

    Satellite Spinal System Surgical Technique, LITSATFUSST7-IRN10612/087, and LIT (DRAFT) Medtronic, Spinal and Biologics Business, Memphis, TN (this guide was originally a portion of the Satellite Spinal System Primary User Group Reference Guide a 8 1/2 by 11 inch plastic binder)

    FDA Recall
    Terminated ·Medtronic Sofamor Danek USA Inc·Product code NVR·September 13, 2007

    IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary to fill the orders.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code NEP·November 8, 2013

    Custom surgical kits: DeRoyal(R) TRAUMA CRANIOTOMY PACK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.01, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 DeRoyal(R) TRAUMA CRANIOTOMY PACK PGYBK, REF 89-7639.02, STERILE EO, Manufactured by: DeRoyal Industries, Inc., Powell, TN 37849 surgical kits

    FDA Recall
    Terminated ·Product code LRP·January 10, 2012

    COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.

    FDA Recall
    Open, Classified ·Copan Diagnostics Inc·Product code JRC·July 14, 2023

    SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable to the intended use of specific devices included in the kit.

    FDA Recall
    Open, Classified ·Cardiac Assist, Inc·Product code DWF·October 14, 2021

    Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation.

    FDA Recall
    Terminated ·Sorin Group Italia S.r.l. Via Crescentino Sn Saluggia Italy·Product code LWR·July 29, 2020

    Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation.

    FDA Recall
    Terminated ·Sorin Group Italia S.r.l. Via Crescentino Sn Saluggia Italy·Product code LWR·July 29, 2020