Edwards Lifesciences recalls

Edwards Lifesciences has 95 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 20 May 2026. 22 are still ongoing. 1 was reported in the last 12 months.

Total recalls95since 2012

Last 12 months1reported

Class I2021% of total

Ongoing22latest 20 May 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 6Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 1 0 0Jul 0 0

Severity split

Class I 20 21%Class II 74 78%Class III 1 1%

Why edwards lifesciences is recalled

Product types

By year

202611%
202566%
20231011%
202244%
20211415%
202033%
20191516%
201844%
201711%
201577%

Ongoing edwards lifesciences recalls

22 active

Reported	Class	Recall	Company	Reason	Where
20 May 2026Device	CLASS II	Edwards Evoque tricuspid delivery system recalled	Edwards Lifesciences	Sterility	Nationwide
16 Jul 2025Device	CLASS I	Optisite Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flexii Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide

All edwards lifesciences recalls, newest first

95 total

Reported	Class	Recall	Company	Reason	Where
20 May 2026Device	CLASS II	Edwards Evoque tricuspid delivery system recalled	Edwards Lifesciences	Sterility	Nationwide
16 Jul 2025Device	CLASS I	Optisite Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flexii Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Fem-flex II Femoral Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
16 Jul 2025Device	CLASS I	Optisite Arterial Cannula recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	Nationwide
6 Dec 2023Device	CLASS II	Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5 recalled	Edwards Lifesciences	Sterility	43 states
6 Dec 2023Device	CLASS II	FloTrac Sensor with Vamp System recalled by Edwards Lifesciences	Edwards Lifesciences	Device Malfunction	43 states
6 Dec 2023Device	CLASS II	TruWave with Vamp System Pressure monitoring set recalled	Edwards Lifesciences	Other	43 states

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.