Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm
Medical device recall Z-0008-2021. Published in FDA’s Enforcement Report on Oct 7, 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 Oct 7, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 900,007 total 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?
The device staples may not properly form upon application preventing adequate hemostasis. Use of a product with this assembly error may result in incomplete staple formation.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Endo GIA Auto Suture Universal Articulating Loading Unit 60 mm - 3.5 mm, Item Code 030458 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis.
900,007 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Numbers: T0A013X T7L050X T8E048X T8K051X T9F118X T0A051X T7L051X T8E055X T8K093X T9G028X T0A085X T7L052X T8E056X T8L129X T9G030X T0B025X T7M021X T8E061X T8L130X T9G038X T0B032X T7M022X T8E062X T8M009X T9G088X T0B046X T8A001X T8E067X…
Every code shown here, 1,340 characters
Lot Numbers: T0A013X T7L050X T8E048X T8K051X T9F118X T0A051X T7L051X T8E055X T8K093X T9G028X T0A085X T7L052X T8E056X T8L129X T9G030X T0B025X T7M021X T8E061X T8L130X T9G038X T0B032X T7M022X T8E062X T8M009X T9G088X T0B046X T8A001X T8E067X T8M011X T9G089X T0B047X T8A002X T8E068X T8M097X T9G090X T0B056X T8A003X T8F001X T9A009X T9G094X T0B073X T8A004X T8F002X T9A031X T9G159X T0B081X T8A045X T8F026X T9A056X T9G160X T0C043X T8A046X T8F045X T9A099X T9H042X T0C068X T8A060X T8F046X T9B001X T9H100X T0C069X T8A061X T8F047X T9B004X T9H101X T0C070X T8B003X T8F077X T9B005X T9H113X T0C103X T8B037X T8H001X T9B038X T9H114X T0D054X T8B038X T8H002X T9C007X T9J030X T0D059X T8B039X T8H003X T9C008X T9J035X T0D061X T8B040X T8H005X T9C069X T9J048X T0D115X T8B041X T8H006X T9C070X T9J073X T0E050X T8C012X T8H019X T9C071X T9J096X T7F019X T8C034X T8H051X T9C156X T9J097X T7F021X T8C035X T8H052X T9E030X T9J098X T7F022X T8C041X T8H072X T9E069X T9K002X T7J003X T8C042X T8J027X T9E070X T9K068X T7J004X T8C044X T8J038X T9E071X T9K104X T7J005X T8D011X T8J041X T9E072X T9K105X T7J013X T8D057X T8J042X T9E111X T9L019X T7J020X T8D058X T8J058X T9E119X T9L074X T7J032X T8D059X T8J067X T9E120X T9L075X T7L028X T8D060X T8K007X T9F026X T9L102X T7L029X T8D061X T8K009X T9F049X T9L103X T7L030X T8D062X T8K043X T9F050X T9M109X T7L048X T8E047X T8K050X T9F078X T9M110X T7L049X
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.
Worldwide distribution - US Nationwide and Global Distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 12, 2020.
- FDA classified it on Oct 1, 2020.
- FDA’s Enforcement Report published it on Oct 7, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Covidien, LP, of North Haven, CT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
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.”
- 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.