FDA Class I Recall: Brand Name: FEM-FLEX II Product Name: Femoral Arterial… by Edwards Lifesciences, LLC

Key facts

What this classification means

A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class I, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.

What consumers should do

Facilities, clinicians, and consumers holding an affected unit or lot of Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Edwards Lifesciences, LLC. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Edwards Lifesciences, LLC should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Edwards Lifesciences, LLC directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.

Edwards Lifesciences, LLC’s FDA history

Argus HQ has recorded 17 total FDA actions tied to Edwards Lifesciences, LLC: 0 warning letters, 17 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the FDA recall number for this event?

FDA recall number Z-2084-2025.

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

Is Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cann recalled?

Yes. FDA lists a Class I recall by Edwards Lifesciences, LLC for Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No, reported 20250716, with status "Ongoing." FDA recall number: Z-2084-2025.

Related enforcement actions

• Recall: Edwards Lifesciences, LLC — Class I recall: Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog N… →
• Recall: Edwards Lifesciences, LLC — Class I recall: Brand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Nu… →
• Recall: Edwards Lifesciences, LLC — Class I recall: Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog N… →
• Recall: Edwards Lifesciences, LLC — Class I recall: Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula… →
• Recall: Edwards Lifesciences, LLC — Class I recall: Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula… →
• Recall: Edwards Lifesciences, LLC — Class II recall: Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only.… →
• Recall: Edwards Lifesciences, LLC — Class II recall: TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in… →
• Recall: Edwards Lifesciences, LLC — Class II recall: FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx on… →