No image published for this recall

No image published for this recall

Edwards Lifesciences - safety alert

Official notice

16 Jul 2025

Last checked

16 Jul 2025

Critical riskFDA

An official FDA notice concerns Edwards Lifesciences - safety alert. An official FDA notice concerns Edwards Lifesciences. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2025-07-16. Recall numbers: Z-2080-2025. Check the official notice for the complete list. Published 2025-07-16.

What to do now

The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.

Units affected

27,022

Recall number

Z-2080-2025

Official notice

2025-07-16

The hazard

An official FDA notice concerns Edwards Lifesciences. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2025-07-16. Recall numbers: Z-2080-2025. Check the official notice for the complete list.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Event Ids

96943

Recall Numbers

Z-2080-2025

Checked manually this time?

The app alerts you when a new official recall is published — no searching, no checking back.

Turn on recall alerts

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States · CA · Irvine

Affected area 1

US · United States · CA · Irvine

Affected area 2

US · United States

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Edwards Lifesciences. Contact: Edwards Lifesciences, LLC.

Source & status

Source

Tier

official

Category

ELECTRONICS

App estimate

critical

Recall details

Recall number

Z-2080-2025

Event id

96943

Units affected

27,022

Status

active

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
Something wrong on this page?

Related recalls

US
No image published for this recall

a product listed in the official notice - safety alert

Medium riskFDA8 Apr 2015
US
No image published for this recall

a product listed in the official notice - safety alert

Medium riskFDA19 Jun 2013
US
No image published for this recall

a product listed in the official notice - safety alert

Medium riskFDA24 Apr 2013
US
No image published for this recall

a product listed in the official notice - safety alert

Medium riskFDA22 Aug 2012
US
No image published for this recall

PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS - safety alert

Medium riskFDA6 Sept 2023
US
No image published for this recall

a product listed in the official notice - safety alert

Medium riskFDA9 Nov 2022
US
No image published for this recall

QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705 - safety alert

Medium riskFDA22 Jan 2020
US
No image published for this recall

a product listed in the official notice - safety alert

Medium riskFDA27 Nov 2019
US
No image published for this recall

a product listed in the official notice - safety alert

Medium riskFDA17 Apr 2019
US
No image published for this recall

a product listed in the official notice - safety alert

Medium riskFDA20 Feb 2019
US
No image published for this recall

Thin-Flex Venous Cannula, Model Number:TF292902A - safety alert

Medium riskFDA16 Dec 2015
US
No image published for this recall

a product listed in the official notice - safety alert

Medium riskFDA13 Nov 2013

Weekly recall digest

Get next week's recalls before you need them.

One email every Monday — official-source recalls for your country, and nothing else. Unsubscribe from any email.

The digest is the slow lane — one email a week. For instant, severity-gated alerts the moment a notice is published, get the app.

This recall was published 16 Jul 2025. The next one won't wait for you to search.

RecallScope watches official sources for the brands and VINs you follow, and alerts you the moment a new notice is published.