Endo GIA Auto Suture Universal Loading Unit 45 mm - 2.5mm
Medical device recall Z-0005-2021. 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 Loading Unit 45 mm - 2.5mm, Item Code 030454 - 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: T0A018X T8B045X T8E051X T8L052X T9E050X T0A106X T8B046X T8E052X T8L101X T9F024X T0B131X T8B047X T8E065X T8L131X T9F037X T0D138X T8C025X T8E066X T8L132X T9F040X T0E011X T8C030X T8H015X T8L143X T9F044X T7G001X T8C031X T8H016X…
Every code shown here, 908 characters
Lot Numbers: T0A018X T8B045X T8E051X T8L052X T9E050X T0A106X T8B046X T8E052X T8L101X T9F024X T0B131X T8B047X T8E065X T8L131X T9F037X T0D138X T8C025X T8E066X T8L132X T9F040X T0E011X T8C030X T8H015X T8L143X T9F044X T7G001X T8C031X T8H016X T8M080X T9F045X T7H004X T8C043X T8H017X T8M092X T9F046X T7H007X T8D001X T8H018X T8M093X T9F097X T7J025X T8D002X T8H049X T8M094X T9G031X T7K018X T8D003X T8J012X T9A006X T9G124X T7K034X T8D004X T8J026X T9A034X T9G125X T7L022X T8D005X T8J039X T9A035X T9H041X T7L036X T8D006X T8J040X T9A118X T9H102X T7L037X T8D014X T8K006X T9B060X T9H110X T8A058X T8D015X T8K008X T9C023X T9J071X T8A059X T8D047X T8L012X T9C024X T9J114X T8A062X T8D048X T8L013X T9C058X T9K077X T8A063X T8D049X T8L014X T9C059X T9L021X T8A064X T8D050X T8L015X T9D053X T9L037X T8A065X T8D051X T8L016X T9D099X T9M017X T8B001X T8D052X T8L049X T9D124X T9M018X T8B002X T8D053X T8L050X T9D125X T9C060X T8B044X T8D054X
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.