Edwards Lifesciences recalls
Edwards Lifesciences appears in 95 official U.S. recall notices indexed by RecallRadar, most recently on 2026-05-20.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
FDA Device · Class II · 2026-05-20 · Edwards Lifesciences - Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: T…
FDA Device · Class I · 2025-07-16 · Edwards Lifesciences - Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product De…
FDA Device · Class I · 2025-07-16 · Edwards Lifesciences - Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: T…
FDA Device · Class I · 2025-07-16 · Edwards Lifesciences - Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description:…
FDA Device · Class I · 2025-07-16 · Edwards Lifesciences - Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: T…
FDA Device · Class I · 2025-07-16 · Edwards Lifesciences - Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product De…
FDA Device · Class I · 2025-07-16 · Edwards Lifesciences - TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241c…
FDA Device · Class II · 2023-12-06 · Edwards Lifesciences - FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only
FDA Device · Class II · 2023-12-06 · Edwards Lifesciences - Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only
FDA Device · Class II · 2023-12-06 · Edwards Lifesciences - TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 c…
FDA Device · Class II · 2023-12-06 · Edwards Lifesciences - Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure moni…
FDA Device · Class II · 2023-12-06 · Edwards Lifesciences - FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only
FDA Device · Class II · 2023-12-06 · Edwards Lifesciences - Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
FDA Device · Class II · 2023-11-15 · Edwards Lifesciences - PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS
FDA Device · Class II · 2023-09-06 · Edwards Lifesciences - Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length…
FDA Device · Class II · 2023-04-19 · Edwards Lifesciences - Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable Len…
FDA Device · Class II · 2023-04-19 · Edwards Lifesciences - Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arteri…
FDA Device · Class II · 2022-11-09 · Edwards Lifesciences - Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
FDA Device · Class II · 2022-11-09 · Edwards Lifesciences - FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA
FDA Device · Class II · 2022-04-06 · Edwards Lifesciences - FORE-SIGHT ELITE Tissue Oximeter module, REF: HEMFSM10
FDA Device · Class II · 2022-04-06 · Edwards Lifesciences - Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommende…
FDA Device · Class II · 2021-08-18 · Edwards Lifesciences - Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO,…
FDA Device · Class II · 2021-08-18 · Edwards Lifesciences - Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewi…
FDA Device · Class II · 2021-08-18 · Edwards Lifesciences - Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommend…
FDA Device · Class II · 2021-08-18 · Edwards Lifesciences - Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile E…
FDA Device · Class II · 2021-08-18 · Edwards Lifesciences - Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommen…
FDA Device · Class II · 2021-08-18 · Edwards Lifesciences - Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylen…
FDA Device · Class II · 2021-07-07 · Edwards Lifesciences - Edwards TruWave (3 cc)/VAMP Jr, REF: VMP406PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)07460691958746
FDA Device · Class II · 2021-07-07 · Edwards Lifesciences - Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370
FDA Device · Class II · 2021-07-07 · Edwards Lifesciences - Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
FDA Device · Class II · 2021-07-07 · Edwards Lifesciences - Edwards TruWave x 2 (3 cc)/VAMP Jr/54 in (136) Kit, REF: T443952B, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethyl…
FDA Device · Class II · 2021-07-07 · Edwards Lifesciences - Edwards TruWave (30 cc)/VAMP Jr/52 in (132 cm) Kit, REF: PXVJ0711, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethyl…
FDA Device · Class II · 2021-07-07 · Edwards Lifesciences - Edwards VAMP Jr. 6 in (15 cm) REF: VMP306, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691944782
FDA Device · Class II · 2021-07-07 · Edwards Lifesciences - Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
FDA Device · Class II · 2021-07-07 · Edwards Lifesciences - Oxymetry Cable, Rxonly
FDA Device · Class II · 2020-05-20 · Edwards Lifesciences - Sterile Oxymetry Oligon Catheter Kit
FDA Device · Class II · 2020-05-20 · Edwards Lifesciences - QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699
FDA Device · Class II · 2020-01-22 · Edwards Lifesciences - EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector , RX Only, Sterile EC, Made in Mexico, UDI: 006901…
FDA Device · Class II · 2019-11-27 · Edwards Lifesciences - Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253
FDA Device · Class I · 2019-08-28 · Edwards Lifesciences - Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239
FDA Device · Class I · 2019-08-28 · Edwards Lifesciences - Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246
FDA Device · Class I · 2019-08-28 · Edwards Lifesciences - Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
FDA Device · Class I · 2019-08-28 · Edwards Lifesciences - IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic o…
FDA Device · Class I · 2019-06-19 · Edwards Lifesciences - EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through t…
FDA Device · Class I · 2019-05-29 · Edwards Lifesciences - Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atri…
FDA Device · Class I · 2019-05-01 · Edwards Lifesciences - Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F Product Usage: The Miller balloon atriosep…
FDA Device · Class I · 2019-05-01 · Edwards Lifesciences - Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elasto…
FDA Device · Class II · 2019-04-17 · Edwards Lifesciences - Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 96…
FDA Device · Class II · 2019-02-20 · Edwards Lifesciences - Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF 151F7 Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnosti…
FDA Device · Class I · 2019-02-06 · Edwards Lifesciences