Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Zenith Alpha Abdominal Endovascular Graft Recalled by Cook Inc. Due to may contain a damaged gray safety lock knob,...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cook Inc. directly.
Affected Products
Zenith Alpha Abdominal Endovascular Graft, Reference Part Numbers: ZIMB-22-108, ZIMB-22-118, ZIMB-22-128, ZIMB-22-70, ZIMB-22-84, ZIMB-22-98, ZIMB-24-108, ZIMB-24-118, ZIMB-24-128, ZIMB-24-70, ZIMB-24-84, ZIMB-24-98, ZIMB-26-108, ZIMB-26-118, ZIMB-26-128, ZIMB-26-70, ZIMB-26-84, ZIMB-26-98, ZIMB-28-108, ZIMB-28-118, ZIMB-28-128, ZIMB-28-70, ZIMB-28-84, ZIMB-28-98, ZIMB-30-108, ZIMB-30-118, ZIMB-30-128, ZIMB-30-70, ZIMB-30-84, ZIMB-30-98, ZIMB-32-108, ZIMB-32-118, ZIMB-32-128, ZIMB-32-70, ZIMB-32-84, ZIMB-32-98, ZIMB-36-108, ZIMB-36-118, ZIMB-36-128, ZIMB-36-70, ZIMB-36-84, ZIMB-36-98
Quantity: 1027
Why Was This Recalled?
may contain a damaged gray safety lock knob, which could potentially result in difficulty or an inability to fully deploy the graft via the standard or troubleshooting method provided in the Instructions for Use (IFU). Potential adverse events that may occur if an affected product is used include a prolonged procedure and open surgical intervention.
Where Was This Sold?
No US distribution. Product distributed to the following foreign countries: Australia, Austria, Belgium, Brazil, Canada, Canary Islands, Chile Columbia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Morocco, Netherlands, Norway, Poland, Portugal, Reunion, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, UK
About Cook Inc.
Cook Inc. has 262 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report