Zenith Alpha Abdominal Endovascular Graft
Medical device recall Z-2964-2020. Published in FDA’s Enforcement Report on Sep 23, 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 Sep 23, 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
- 684 units 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?
May contain excess glue within the handle of the delivery system, resulting in an inability to fully deploy the graft via the standard method or troubleshooting deployment 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 - Distributed OUS only. Indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms Reference Part Number (RPN): 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-32-108 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-36-84 ZIMB-36-98
684 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Reference Part / Lot Numbers : ZIMB-22-108 9182141, 9983461, 10010790, 10136649, 13023971; ZIMB-22-118 10077065; ZIMB-22-70 9170948, 9196501, 9196502, 9311502, 9415647, 10156546, 10275239, 10337923; ZIMB-22-84 9100087, 9100089, 9118160,…
Every code shown here, 1,999 characters
Reference Part / Lot Numbers : ZIMB-22-108 9182141, 9983461, 10010790, 10136649, 13023971; ZIMB-22-118 10077065; ZIMB-22-70 9170948, 9196501, 9196502, 9311502, 9415647, 10156546, 10275239, 10337923; ZIMB-22-84 9100087, 9100089, 9118160, 9124830, 9132423, 9182145, 9403140, 9415636, 9415637, 9964029,9964055, 9974798, 9974799, 10153964,10153965, 10337925; ZIMB-22-98 9108371, 9163902, 9406786, 10136631, 10275243; ZIMB-24-108 9338301, 9854089, 9936720, 9936722, 9939734, 9939736, 9945749, 9945751, 9945753, 10318498; ZIMB-24-118 9100111, 9163853, 9959252, 9995361, 9999386, 10275245; ZIMB-24-128 9136557; ZIMB-24-70 9084499, 9118179, 9118180, 9163859, 9184781, 9196487, 9196590, 9300915, 9311508, 9338304,9978260, 9978261, 9983464, 10291632,13023978; ZIMB-24-84 9084507, 9118182, 9118183, 9118406, 9118409, 9163906, 9181250, 9196491, 9196593, 9279116, 9292346, 9321079, 9321083, 9324519, 9324521,9330492, 9330493, 9338306, 9365311, 9409601, 9409602, 9409604, 9959219, 9964025, 9964027,9964028, 9983471, 10017280, 10044210,10141902, 10141911, 10175395, 10175409, 10291637, 10291638, 10305523, 10305524,10332829, 10340274, 10340279, 13008932,13011201, 13020521, 13035543, 13041249,10056663XX, NS9088555; ZIMB-24-98 9076897, 9080500, 9080501, 9084510, 9084512, 9100134, 9100135, 9102515, 9118415, 9173828, 9321095, 9365312, 9373635, 9415651, 9964064,9969873, 9974816, 10052850, 10077067, 10098962, 10151099, 10186652, 13041251; ZIMB-26-108 9100142, 9163915, 9373477, 9904753, 9915021, 9930826, 9936725, 9936733, 9936734, 9953748, 10010796, 10010836, 10025525, 10108021,10175397, 10299712, 10309872, 13023989, 13023990; ZIMB-26-118 9286115, 10105275, 10299413, 13011587,13023992; ZIMB-26-70 9100151, 9217933, 9373479, 9373646, 9419035, 9425597, 9425598, 9915028, 9915029, 9915030,9995377, 9999389, 10025531, 10077068,13011591, 13015424, 13021170, 13023993, 13027639; ZIMB-26-84 9076909, 9076928, 9088530, 9118164, 9124843, 9196498, 9303243, 9303253, 9314216, 9321168, 9415652, 9415653, 9936744, 9978265,…
FDA’s list runs to 6,771 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 Only: Canada SWEDEN AUSTRIA Belgium CZECH REPUBLIC DENMARK ESPA¿A FINLAND France GERMANY GREECE HUNGARY IRELAND ISRAEL Italia Nederland NORWAY POLAND PORTUGAL REUNION SERBIA SLOVENIA SOUTH AFRICA SWEDEN UNITED ARAB EMIRATES UNITED KINGDOM AUSTRALIA Hong Kong JAPAN NEW CALEDONIA New Zealand 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 Aug 11, 2020.
- FDA classified it on Sep 11, 2020.
- FDA’s Enforcement Report published it on Sep 23, 2020.
- FDA terminated it on Jul 28, 2021.
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 6,771 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
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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.