Severity
Critical
Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part 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 ZTA2-P-42-225 ZTA2-P-42-225-W ZTA2-P-44-125 ZTA2-P-44-125-W ZTA2-P-44-179 ZTA2-P-44-179-W ZTA2-P-44-233 ZTA2-P-44-233-W ZTA2-P-46-125 ZTA2-P-46-125-W ZTA2-P-46-179 ZTA2-P-46-179-W ZTA2-P-46-233-W ZTA2-PT-40-36-167 ZTA2-PT-40-36-167-W ZTA2-PT-40-36-217 ZTA2-PT-40
Reported: October 22, 2025 Initiated: September 18, 2025 #Z-0043-2026 695 units
Cook Medical Incorporated issued this FDA Devices recall on October 22, 2025. Classified as Critical severity (Class I). Approximately 695 units are affected. The recall was issued because: Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially …. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.
Recall Insight
This FDA Devices action (record #Z-0043-2026) was formally reported on October 22, 2025, with the manufacturer initiating the action on September 18, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Cook Medical Incorporated is listed as the recalling firm, operating out of Bloomington, IN. Federal records indicate 695 units are affected.
The documented reason for this recall is: Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization. Distribution data in the federal record shows the product reached: 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, and Sweden. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Recall Distribution by Severity Class
Units Affected
695
Related Recalls
6
6 from same agency
Recall Progress (industry avg ~60%) 60.0%
Product Description
Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part 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 ZTA2-P-42-225 ZTA2-P-42-225-W ZTA2-P-44-125 ZTA2-P-44-125-W ZTA2-P-44-179 ZTA2-P-44-179-W ZTA2-P-44-233 ZTA2-P-44-233-W ZTA2-P-46-125 ZTA2-P-46-125-W ZTA2-P-46-179 ZTA2-P-46-179-W ZTA2-P-46-233-W ZTA2-PT-40-36-167 ZTA2-PT-40-36-167-W ZTA2-PT-40-36-217 ZTA2-PT-40-36-217-W ZTA2-PT-42-38-173 ZTA2-PT-42-38-173-W ZTA2-PT-42-38-225 ZTA2-PT-42-38-225-W ZTA2-PT-44-40-179 ZTA2-PT-44-40-179-W ZTA2-PT-44-40-233-W ZTA2-PT-46-42-179 ZTA2-PT-46-42-179-W ZTA2-PT-46-42-233 ZTA2-PT-46-42-233-W ZTA2-P-46-233 ZTA2-PT-44-40-233 ZTA2-P-40-217 ZTA2-P-40-117 ZTA2-P-40-167-DEMO ZTA2-P-44-152-W ZTA2-P-40-142 ZTA2-P-44-152 ZTA2-P-40-142-W
Reason for Recall
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
Details
- Recalling Firm
- Cook Medical Incorporated
- Units Affected
- 695
- Distribution
- 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, and Sweden
- Location
- Bloomington, IN
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0043-2026 |
| Date reported | October 22, 2025 |
| Date initiated | September 18, 2025 |
| Recalling firm | Cook Medical Incorporated |
| Units affected | 695 |
| Distribution | 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, and Sweden |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part 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 ZTA2-P-42-225 ZTA2-P-42-225-W ZTA2-P-44-125 ZTA2-P-44-125-W ZTA2-P-44-179 ZTA2-P-44-179-W ZTA2-P-44-233 ZTA2-P-44-233-W ZTA2-P-46-125 ZTA2-P-46-125-W ZTA2-P-46-179 ZTA2-P-46-179-W ZTA2-P-46-233-W ZTA2-PT-40-36-167 ZTA2-PT-40-36-167-W ZTA2-PT-40-36-217 ZTA2-PT-40-36-217-W ZTA2-PT-42-38-173 ZTA2-PT-42-38-173-W ZTA2-PT-42-38-225 ZTA2-PT-42-38-225-W ZTA2-PT-44-40-179 ZTA2-PT-44-40-179-W ZTA2-PT-44-40-233-W ZTA2-PT-46-42-179 ZTA2-PT-46-42-179-W ZTA2-PT-46-42-233 ZTA2-PT-46-42-233-W ZTA2-P-46-233 ZTA2-PT-44-40-233 ZTA2-P-40-217 ZTA2-P-40-117 ZTA2-P-40-167-DEMO ZTA2-P-44-152-W ZTA2-P-40-142 ZTA2-P-44-152 ZTA2-P-40-142-W. Recalled by Cook Medical Incorporated. Units affected: 695.
Why was this product recalled? ▼
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 22, 2025. Severity: Critical. Recall number: Z-0043-2026.
Where was the recalled product distributed? ▼
Distribution: 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, and Sweden.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0043-2026) 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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Data Sources
Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).