| Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO recall (Z-2172-2026) | Edwards Lifesciences, LLC | 2026-05-13 |
| Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalo recall (Z-2080-2025) | Edwards Lifesciences, LLC | 2025-07-10 |
| Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalo recall (Z-2081-2025) | Edwards Lifesciences, LLC | 2025-07-10 |
| Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII recall (Z-2082-2025) | Edwards Lifesciences, LLC | 2025-07-10 |
| Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII recall (Z-2083-2025) | Edwards Lifesciences, LLC | 2025-07-10 |
| Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII recall (Z-2084-2025) | Edwards Lifesciences, LLC | 2025-07-10 |
| Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII0 recall (Z-2085-2025) | Edwards Lifesciences, LLC | 2025-07-10 |
| Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, S recall (Z-0409-2024) | Edwards Lifesciences, LLC | 2023-11-29 |
| Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use i recall (Z-0410-2024) | Edwards Lifesciences, LLC | 2023-11-29 |
| FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For us recall (Z-0411-2024) | Edwards Lifesciences, LLC | 2023-11-29 |
| FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For us recall (Z-0412-2024) | Edwards Lifesciences, LLC | 2023-11-29 |
| TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), P recall (Z-0413-2024) | Edwards Lifesciences, LLC | 2023-11-29 |
| TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAV recall (Z-0414-2024) | Edwards Lifesciences, LLC | 2023-11-29 |
| Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 recall (Z-0238-2024) | Edwards Lifesciences, LLC | 2023-11-06 |
| PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS recall (Z-2479-2023) | Edwards Lifesciences, LLC | 2023-08-29 |
| Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Cath recall (Z-1379-2023) | Edwards Lifesciences, LLC | 2023-04-12 |
| Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Cat recall (Z-1380-2023) | Edwards Lifesciences, LLC | 2023-04-12 |
| Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 1 recall (Z-0146-2023) | Edwards Lifesciences, LLC | 2022-10-28 |
| Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP recall (Z-0147-2023) | Edwards Lifesciences, LLC | 2022-10-28 |
| Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)006901 recall (Z-2007-2020) | Edwards Lifesciences, LLC | 2020-07-10 |
| Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSp recall (Z-1928-2020) | Edwards Lifesciences, LLC | 2020-05-08 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) ( recall (Z-2224-2019) | Edwards Lifesciences, LLC | 2019-08-21 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) ( recall (Z-2225-2019) | Edwards Lifesciences, LLC | 2019-08-21 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) ( recall (Z-2226-2019) | Edwards Lifesciences, LLC | 2019-08-21 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) ( recall (Z-2227-2019) | Edwards Lifesciences, LLC | 2019-08-21 |
| IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), recall (Z-1705-2019) | Edwards Lifesciences, LLC | 2019-06-11 |
| EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monit recall (Z-1193-2019) | Edwards Lifesciences, LLC | 2019-05-21 |
| Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: recall (Z-1116-2019) | Edwards Lifesciences, LLC | 2019-04-25 |
| Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 8 recall (Z-1117-2019) | Edwards Lifesciences, LLC | 2019-04-25 |
| Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan recall (Z-0762-2019) | Edwards Lifesciences, LLC | 2019-01-31 |
| Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131F7P (5 pack of 131F7) Produ recall (Z-0763-2019) | Edwards Lifesciences, LLC | 2019-01-31 |
| Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 131VF7P Product Usage: The Swa recall (Z-0764-2019) | Edwards Lifesciences, LLC | 2019-01-31 |
| Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan- recall (Z-0765-2019) | Edwards Lifesciences, LLC | 2019-01-31 |
| Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Sw recall (Z-0496-2018) | Edwards Lifesciences, LLC | 2018-01-16 |
| Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 960 recall (Z-0293-2018) | Edwards Lifesciences, LLC | 2018-01-10 |
| Thin-Flex Venous Cannula, Model Number:TF292902A recall (Z-0398-2016) | Edwards Lifesciences, LLC | 2015-12-09 |
| ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the Thru recall (Z-2780-2015) | Edwards Lifesciences, LLC | 2015-09-18 |
| Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 F recall (Z-1758-2015) | Edwards Lifesciences, LLC | 2015-06-11 |
| ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and Cl recall (Z-1732-2015) | Edwards Lifesciences, LLC | 2015-06-09 |
| Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed p recall (Z-1700-2015) | Edwards Lifesciences, LLC | 2015-06-02 |
| Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx recall (Z-1371-2015) | Edwards Lifesciences, LLC | 2015-04-02 |
| Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, pee recall (Z-0217-2015) | Edwards Lifesciences, LLC | 2014-11-14 |
| Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, recall (Z-1466-2014) | Edwards Lifesciences, LLC | 2014-04-16 |
| Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arter recall (Z-1467-2014) | Edwards Lifesciences, LLC | 2014-04-16 |
| Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Tr recall (Z-0918-2014) | Edwards Lifesciences, LLC | 2014-02-03 |
| Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model recall (Z-0560-2014) | Edwards Lifesciences, LLC | 2013-12-21 |
| Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, recall (Z-0134-2014) | Edwards Lifesciences, LLC | 2013-11-01 |
| Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX recall (Z-0135-2014) | Edwards Lifesciences, LLC | 2013-11-01 |
| Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, E recall (Z-0091-2014) | Edwards Lifesciences, LLC | 2013-10-31 |
| "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when a recall (Z-2189-2013) | Edwards Lifesciences, LLC | 2013-09-11 |
| Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512 recall (Z-1963-2013) | Edwards Lifesciences, LLC | 2013-08-14 |
| Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort End recall (Z-1972-2013) | Edwards Lifesciences, LLC | 2013-08-14 |
| Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for h recall (Z-1749-2013) | Edwards Lifesciences, LLC | 2013-07-17 |
| QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD2 recall (Z-1542-2013) | Edwards Lifesciences, LLC | 2013-06-13 |
| Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product recall (Z-1322-2013) | Edwards Lifesciences, LLC | 2013-05-14 |
| Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXV recall (Z-1146-2013) | Edwards Lifesciences, LLC | 2013-04-18 |
| Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcat recall (Z-1134-2013) | Edwards Lifesciences, LLC | 2013-04-17 |
| Edwards Lifesciences Crimpers, Model 9100CR26. The Crimpers are used to crimp the transcat recall (Z-1135-2013) | Edwards Lifesciences, LLC | 2013-04-17 |
| Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are inten recall (Z-1111-2013) | Edwards Lifesciences, LLC | 2013-04-14 |
| Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patie recall (Z-2188-2012) | Edwards Lifesciences, LLC | 2012-08-12 |
| Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patie recall (Z-2189-2012) | Edwards Lifesciences, LLC | 2012-08-12 |
| Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in pati recall (Z-2190-2012) | Edwards Lifesciences, LLC | 2012-08-12 |
| Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in pati recall (Z-2191-2012) | Edwards Lifesciences, LLC | 2012-08-12 |
| Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in pat recall (Z-2192-2012) | Edwards Lifesciences, LLC | 2012-08-12 |
| Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in patien recall (Z-2193-2012) | Edwards Lifesciences, LLC | 2012-08-12 |
| Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in pati recall (Z-2194-2012) | Edwards Lifesciences, LLC | 2012-08-12 |
| Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in pati recall (Z-2195-2012) | Edwards Lifesciences, LLC | 2012-08-12 |
| Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patien recall (Z-2196-2012) | Edwards Lifesciences, LLC | 2012-08-12 |
| Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patie recall (Z-2197-2012) | Edwards Lifesciences, LLC | 2012-08-12 |
| Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in pat recall (Z-2198-2012) | Edwards Lifesciences, LLC | 2012-08-12 |
| Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product recall (Z-1967-2012) | Edwards Lifesciences, LLC | 2012-07-09 |
| Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51, 00.60, 00.61, 00.62, 00.6 recall (Z-0942-2012) | Edwards Lifesciences, Llc | 2012-02-02 |
| Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9", Sterile EO, Sterile R, Edwards Lifes recall (Z-2776-2011) | Edwards Lifesciences, LLC | 2011-07-11 |
| Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards Lifescien recall (Z-2777-2011) | Edwards Lifesciences, LLC | 2011-07-11 |
| Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, recall (Z-2196-2011) | Edwards Lifesciences Llc | 2011-05-13 |
| EndoPlege Sinus Catheter Kit, REF EP, 9 Fr x 18.9", Contains Phthalates, Sterile EO, Steri recall (Z-0991-2011) | Edwards Lifesciences Llc | 2011-01-28 |
| Steerable Coronary Sinus Catheter Kit, REF SCS01, 9 Fr x 20.4", Contains Phthalates, Steri recall (Z-0992-2011) | Edwards Lifesciences Llc | 2011-01-28 |
| Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO, Edwa recall (Z-0542-2011) | Edwards Lifesciences Llc | 2010-12-07 |
| Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO, Edwar recall (Z-0543-2011) | Edwards Lifesciences Llc | 2010-12-07 |
| Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 The Edwards Lifesciences Analo recall (Z-0160-2011) | Edwards Lifesciences, Llc | 2010-10-28 |
| Edwards Lifesciences Aquarius System Model GEF09800. recall (Z-0653-2010) | Edwards Lifesciences, Llc | 2010-01-27 |
| Edwards Lifesciences Fogaty Occlusion Catheter Ref # 62080822F. The product is intended fo recall (Z-0002-2010) | Edwards Lifesciences, Llc | 2009-11-10 |
| Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only. In recall (Z-1913-2009) | Edwards Lifesciences, Llc | 2009-08-25 |
| Edwards Lifesciences Swan-Ganz Thermodilution Catheter REF: 139F75 For use inpatients who recall (Z-1238-2009) | Edwards Lifesciences, Llc | 2009-04-17 |
| Edwards Lifesciences Swan-Ganz Intellicath CCO/VIP Thermodilution Catheter with AMC Thromb recall (Z-1239-2009) | Edwards Lifesciences, Llc | 2009-04-17 |
| Edwards Lifesciences Swan-Ganz Thermodilution Catheter with AMC THROMBOSHIELD (An Antimicr recall (Z-1240-2009) | Edwards Lifesciences, Llc | 2009-04-17 |
| Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2 Thermodilution Catheter with AMC THROMBOSH recall (Z-1241-2009) | Edwards Lifesciences, Llc | 2009-04-17 |
| Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter For use with V recall (Z-1242-2009) | Edwards Lifesciences, Llc | 2009-04-17 |
| Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter with AMC THROM recall (Z-1243-2009) | Edwards Lifesciences, Llc | 2009-04-17 |
| Edwards Lifesciences***Fogarty Fortis***Arterial Embolectomy Catheter Is indicated for the recall (Z-0013-2009) | Edwards Lifesciences, LLC | 2008-10-03 |
| Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model N recall (Z-1246-2008) | Edwards Lifesciences, Llc | 2008-07-02 |
| Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model N recall (Z-1247-2008) | Edwards Lifesciences, Llc | 2008-07-02 |
| Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model N recall (Z-1248-2008) | Edwards Lifesciences, Llc | 2008-07-02 |
| Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model N recall (Z-1249-2008) | Edwards Lifesciences, Llc | 2008-07-02 |
| Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model N recall (Z-1250-2008) | Edwards Lifesciences, Llc | 2008-07-02 |
| Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model N recall (Z-1251-2008) | Edwards Lifesciences, Llc | 2008-07-02 |
| Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model N recall (Z-1252-2008) | Edwards Lifesciences, Llc | 2008-07-02 |
| Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model N recall (Z-1253-2008) | Edwards Lifesciences, Llc | 2008-07-02 |
| Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model N recall (Z-1254-2008) | Edwards Lifesciences, Llc | 2008-07-02 |
| Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model N recall (Z-1255-2008) | Edwards Lifesciences, Llc | 2008-07-02 |