Edwards Lifesciences, LLC: 48 recalls on record

Recalls filed with 1 agency: FDA (48).

First recall on record: July 18, 2012. Most recent: May 20, 2026.

Risk classification: Class I: 10 · Class II: 37 · Class III: 1

Most recent recalls

DateAgencyProduct
November 6, 2013FDAEdwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, …Z-0091-2014
September 18, 2013FDA"***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures wh…Z-2189-2013
August 21, 2013FDAEdwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPor…Z-1972-2013
August 21, 2013FDAEdwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS1751…Z-1963-2013
July 24, 2013FDAEdwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended f…Z-1749-2013
June 19, 2013FDAQuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD…Z-1542-2013
May 22, 2013FDAProplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Pro…Z-1322-2013
April 24, 2013FDAPressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PX…Z-1146-2013
April 24, 2013FDAEdwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae …Z-1111-2013
April 24, 2013FDAEdwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the tr…Z-1135-2013
April 24, 2013FDAEdwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the tr…Z-1134-2013
August 22, 2012FDAEdwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in p…Z-2188-2012
August 22, 2012FDAEdwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in pa…Z-2196-2012
August 22, 2012FDAEdwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in pa…Z-2193-2012
August 22, 2012FDAEdwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in p…Z-2189-2012
August 22, 2012FDAEdwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in …Z-2194-2012
August 22, 2012FDAEdwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in …Z-2190-2012
August 22, 2012FDAEdwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in …Z-2195-2012
August 22, 2012FDAEdwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in…Z-2198-2012
August 22, 2012FDAEdwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in p…Z-2197-2012
August 22, 2012FDAEdwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in …Z-2191-2012
August 22, 2012FDAEdwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in…Z-2192-2012
July 18, 2012FDAEdwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. P…Z-1967-2012

Questions about this company

How many recalls does Edwards Lifesciences, LLC have?
Recalert has 48 U.S. recalls on record for Edwards Lifesciences, LLC, published between July 18, 2012 and May 20, 2026.
Which agencies have handled Edwards Lifesciences, LLC recalls?
Edwards Lifesciences, LLC appears as the recalling firm in recalls from: FDA (48).

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