Zenith Alpha Abdominal Endovascular Graft
Medical device recall Z-2546-2020. Published in FDA’s Enforcement Report on Jul 15, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 15, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 571 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Identified products may contain a damaged bushing within the delivery system, which could potentially result in difficulty or an inability to fully deploy the graft via the standard method provided in the IFU.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair.
571, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
10225099 13086631 10236496 10236495 13086628 13086629 13086630 10199454 10199470 10248188 10248189 10205533 10205533X 10261154 10262338 10262339 10262340 10208616 10208617 10222621 10216004 10225098 10236497 10241031 10242503 10242504…
Every code shown here, 1,993 characters
10225099 13086631 10236496 10236495 13086628 13086629 13086630 10199454 10199470 10248188 10248189 10205533 10205533X 10261154 10262338 10262339 10262340 10208616 10208617 10222621 10216004 10225098 10236497 10241031 10242503 10242504 10248190 13086633 10208619 10208618 10215770 10222622 10236499 10236498 10242505 10258804 10265109 13059620 13090275 10238909 10245880 10248214 10250362 13098164 10250364 10250361 10262345 10262346 10269483 10250363 10222636 13059866 10233563 10291651 10236429 10238910 10238912 10238913 10238914 10238916 10241034 10241034X 13094887 10238911 10238915 10241502 10238903 10245881 10247236 10247237 10247238 10247235 13086610 10249320 10249321 10250370 10250371 10199450 10199477 10199463 10199467 10199478 10204345 10205528 10238917 10250366 13098165 10205525 10205527 10250365 10250367 10251227 10250372 10250373 10250374 10205526 10250368 10250369 10269485 10199475 10204346 10269486 10271377 10205529 10205539 10211500 10223548 10271376 13041265 10211497 10211498 10211499 10215409 10215410 10215414 10216007 10222637 10222638 10222639 10223547 10225108 10222639X 10235877 10233109 10228473 10233539 10233555 10233556 10236430 10291801 10238918 10238919 10238920 10238921 13086635 13094890 13086611 13094858 13094891 10251230 10291802 10205530 10251229 10252366 13094892 10205531 10251228 10251231 10251232 10251233 10251234 10251235 10205516 10205532 10211502 10211503 10212863 10211501 10212862 10223551 10223552 10223553 10223554 10223555 10225109 10225110 10233554 10233106 10233553 10240704 10241033 10240704X 10248205 10248208 13086609 10248206 10248204 10248207 10250358 10250359 10250360 10265111 10208632 10208633 10211493 10225105 10208631 10211492 10222630 10222632 10222633 10225104 10225106 10222631 10225107 13094856 10248209 13094883 10299723 13090272 10248210 10207216 10207217 10210137 10211494 10211495 10222634 10222635 13035556 10248211 10248212 10248213 13086634 10200936 10258806 10262344 10205562 10211496 13035557 13074779 10238782…
FDA’s list runs to 7,249 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Foreign distribution to the countries of Canada, Chile, Argentina, Colombia, Great Britain, AUSTRIA Belgium. CZECH REPUBLIC DENMARK ESPA¿A France GERMANY GREECE HUNGARY ICELAND IRELAND ISRAEL Italia MARTINIQUE Nederland NORWAY POLAND PORTUGAL SERBIA SOUTH AFRICA SWEDEN UNITED KINGDOM Australia Hong Kong Thailand
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 2, 2020.
- FDA classified it on Jul 9, 2020.
- FDA’s Enforcement Report published it on Jul 15, 2020.
- FDA terminated it on May 5, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cook Inc., of Bloomington, IN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 7,249 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.