41 results
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24ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code NHJ·May 30, 2024
Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code NHJ·May 30, 2024
In-Line ventilator adaptor
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code NHJ·April 26, 2022
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code NHJ·February 18, 2026
Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
FDA Recall
Open, Classified
·Percussionaire Corporation·Product code NHJ·September 16, 2024
In-Line ventilator adaptor
FDA Recall
Terminated
·Baxter Healthcare Corporation·Product code NHJ·April 26, 2022
VITROS Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS Chemistry Products DT Calibrator Kit lot 44 (Product Code 1957927) and tested on the VITROS DT60/DT60 II Chemistry System: IVD, Made in USA by Ortho-Clinical Diagnostics, Inc. Rochester, NY
FDA Recall
Terminated
·Ortho-Clinical Diagnostics·Product code JIX·July 15, 2014
Alkaline Phosphatase Substrate Mfg. for Alfa Wassermann Diagnostic Technologies LLC, Caldwell, N.J. in 2.1 mL and 7.5mL containers. In vitro diagnostic.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CJE·June 9, 2006
Alkaline Phosphatase Buffer Mfg. for Alfa Wassermann Diagnostic Technologies LLC, Caldwell, N.J. in 8.4 mL and 30 mL containers. In vitro diagnostic.
FDA Recall
Terminated
·Pointe Scientific, Inc.·Product code CJE·June 9, 2006
AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
FDA Recall
Terminated
·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code JIF·July 30, 2020
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
FDA Recall
Terminated
·RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom·Product code JIF·July 30, 2020
ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a ''Stapler, reload, TR35W, TR776, TCR 75, TCR 55, TRT75,
FDA Recall
Terminated
·International Surgical Supply, Inc.·Product code KDC·September 3, 2003
ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Stapler EMS Endo Hernia , item # 8034.
FDA Recall
Terminated
·International Surgical Supply, Inc.·Product code KDC·September 3, 2003
ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Thoracic Trocar Sleeve, rounded tip, Item # TT012.
FDA Recall
Terminated
·International Surgical Supply, Inc.·Product code KDC·September 3, 2003
ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Stapler, Articulating, Linear, item # AX55
FDA Recall
Terminated
·International Surgical Supply, Inc.·Product code KDC·September 3, 2003
ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Cutter, ETS Endoscopic Linear, 35 mm, item # TSB 35.
FDA Recall
Terminated
·International Surgical Supply, Inc.·Product code KDC·September 3, 2003
ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Linear Cutter, Thick tissue 75 mm, item code TCT75.
FDA Recall
Terminated
·International Surgical Supply, Inc.·Product code KDC·September 3, 2003
ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Trocar, Tristar, blunt tip, item 512B.
FDA Recall
Terminated
·International Surgical Supply, Inc.·Product code KDC·September 3, 2003
ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Cutter, Linear Vascular, Item # TSB-35.
FDA Recall
Terminated
·International Surgical Supply, Inc.·Product code KDC·September 3, 2003
ETHICON brand surgical device with an added label with the labeling Manufactured by: MedSurg Solutions, 3025 Harbor Lane suite 104 Plymouth, MN 55447 and/or another additional label which states MEDSURG 3025 Harbor Lane, Suite 104, Plymouth, MN 55447 Steriliation Date:. The product labels also state the following firm: ETHICON, INC. SOMERVILLE, N.J. 08876-0151 The product described on label is a: Stapler, Posered LDS Single Use, item # 092001
FDA Recall
Terminated
·International Surgical Supply, Inc.·Product code KDC·September 3, 2003