Quick Facts at a Glance
- Recall Date
- September 18, 2025
- Hazard Level
- HIGH
- Brand
- Cook Medical
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- Nationwide (50 states)
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Cook Medical
- Product type
- Thoracic Endovascular Graft
- Model numbers
- ZTA2-P-40-117-W, ZTA2-P-40-167, ZTA2-P-40-167-W, ZTA2-P-40-217-W, ZTA2-P-42-121, ZTA2-P-42-121-W, ZTA2-P-42-173, ZTA2-P-42-173-W +38 more
- Sold at
- Unknown
- Where affected
- Nationwide
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 18, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cook Medical Incorporated or your healthcare provider for instructions. Notification method: Letter
About This Product
The Zenith Alpha 2 line comprises thoracic endovascular grafts used to treat thoracic aortic pathologies. They are implanted by vascular surgeons to reinforce the aorta. The devices are part of a broader class of stent grafts often used in endovascular repair.
Why This Is Dangerous
PTFE coating scrapings may be present on the grafts. During deployment, scrapings could detach and travel within the bloodstream, potentially causing embolization.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and patients may face procedure delays or revision surgeries. The recall emphasizes careful device verification and adherence to recall instructions to prevent serious complications.
Practical Guidance
How to identify if yours is affected
- Verify catalog prefix ZTA2.
- Cross-check reference part numbers listed in the recall with your device lid and packaging.
- Inspect for corresponding UDI-DI and lot numbers from the recall list.
Where to find product info
Device labels include UDI-DI. Recall notices provide box UDI-DI, product UDI-DI, and lot numbers.
What timeline to expect
Timeline for refunds or replacements is not specified in the recall notice.
If the manufacturer is unresponsive
- Escalate with hospital procurement and risk management.
- Request formal recall documentation and a written plan from the supplier.
- File a report with FDA MedWatch if the supplier is unresponsive.
How to prevent similar issues
- Institute strict UDI and lot-number verification for all thoracic endovascular grafts.
- Request up-to-date recall status from suppliers and distributors.
- Educate surgical teams on recognizing recall items during inventory checks.
Documentation advice
Keep all recall notices, packaging, UDI codes, lot numbers, and correspondence with the manufacturer for records.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Domestic distribution to AL, AR, AZ, CA, CT, DC, DE, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NJ,
- NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV
- International distribution to Switzerland, Germany, Italy, Poland, Sweden
- Recall date: 2025-09-18; Report date: 2025-10-22
- Hazard: PTFE coating scrapings could cause intravascular embolization
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Safety Guide
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