Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported July 16, 2025
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS 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
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Edwards Lifesciences, LLC recalled Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FE… - a critical-severity action.
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FE… was recalled by Edwards Lifesciences, LLC in July 16, 2025. Reason: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula bod…. Check the official notice for the remedy. Verify recall #Z-2083-2025 with the FDA Devices before acting.
The recall
Edwards Lifesciences, LLC issued this critical-severity FDA Devices recall-due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula bod….
- Critical
- severity level
- 847 units
- affected scope
- Class I
- classification
- July 16, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2083-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2083-2025) was formally reported on July 16, 2025, with the manufacturer initiating the action on May 14, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Edwards Lifesciences, LLC is listed as the recalling firm, operating out of Irvine, CA. Federal records list the affected scope as 847.
The documented reason for this recall is: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. Distribution data in the federal record shows the product reached: Worldwide - US Nationwide distribution including in the states of ALABAMA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
847
Related Recalls
6
3 from same agency
Product description
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS 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
Reason for recall
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-2083-2025 |
| Date reported | July 16, 2025 |
| Date initiated | May 14, 2025 |
| Recalling firm | Edwards Lifesciences, LLC |
| Firm location | Irvine, CA |
| Affected scope | 847 |
| Distribution | Worldwide - US Nationwide distribution including in the states of ALABAMA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY, … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2083-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Brand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS 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. Recalled by Edwards Lifesciences, LLC. Units affected: 847.
Why was this product recalled? ▼
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 16, 2025. Severity: Critical. Recall number: Z-2083-2025.
Where was the recalled product distributed? ▼
Distribution: Worldwide - US Nationwide distribution including in the states of ALABAMA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY, LOUISIANA, MAINE, MARYLAND, MASSACHUSETTS, MICHIGAN, MINNESOTA, MISSISSIPPI, MISSOURI, MONTANA, NEBRASKA, NEVADA, NEW HAMPSHIRE, NEW JERSEY, NEW MEXICO, NEW YORK, NORTH CAROLINA, NORTH DAKOTA, OHIO, OKLAHOMA, OREGON, PENNSYLVANIA, Puerto Rico, RHODE ISLAND, SOUTH CAROLINA, SOUTH DAKOTA, TENNESSEE, TEXAS, UTAH, VIRGINIA, WASHINGTON, WEST VIRGINIA, WISCONSIN and the countries of Albania, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, CANARY ISLANDS, Chile, Colombia, Cyprus, Czech Republic, Denmark, France, Germany, Greece, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Malta, Netherlands, Northern Ireland, Norway, Pakistan, Panama, Poland, Portugal, Romania, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates (UAE), United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2083-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 16, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.