“Cordis Avanti+ Catheter Sheath Introducer: Product Too Large for Labeling.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62361-cordis-avanti-catheter-sheath-introducer-product-too-large-for-labeling. Based on FDA recall #Z-2079-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2079-2021%22&limit=1).
The FDA announced on June 9, 2021, that Cordis Corporation voluntarily recalled Avanti¿+ Catheter Sheath Introducers because the product size exceeds labeling specifications. The agency issued recall number Z-2079-2021 for the Class II device.
How to tell if you have it
Brand: Cordis
Product: Avanti¿+ Catheter Sheath Introducer
Catalog: 504-657A
Lot 17919780: Exp. Date 12/31/2022
Lot 17988227: Exp. Date 10/31/2023
The hazard
According to the FDA, the product in the packaging is larger, both in inner and outer diameter, than the labeling indicates.
Context
GovInfoNow's records show Cordis Corporation has 9 other recalls on record since 2017-11-15. Other recent recalls of similar products include BD InLay Optima Ureteral Stent Kit (2025-11-06), Arrow Percutaneous Sheath Introducer Recall (2026-03-11), and Micro Therapeutics Pipeline Flex Embolization Device (2026-06-08).
How to tell if you have this one
Check for the product name 'Avanti+ Catheter Sheath Introducer' with catalog numbers 504-657A. Lot numbers 17919780 (expiring 12/31/2022) and 17988227 (expiring 10/31/2023) are also indicators.
Brand
Cordis
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the catalog number 504-657A and lot numbers 17919780 or 17988227 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 8 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of AR, AZ, FL, GA, IN, NC, NJ, and WV. The country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, Florida, Georgia, Indiana, New Jersey, North Carolina, West Virginia.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2079-2021 (June 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2079-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.