EGIA 45 ARTICULATING MED THICK SULU
Medical device recall Z-1826-2019. Published in FDA’s Enforcement Report on Jun 26, 2019.
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 Jun 26, 2019. 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
- 3,113,280 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 may be missing one of two pin components that maintain alignment of the device jaws, resulting in incomplete staple formation which may lead to bleeding, anastomotic leak, peritonitis, or pneumothorax which can result in the potential for infection and/or sepsis.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
EGIA 45 ARTICULATING MED THICK SULU, Item Code EGIA45AMT
3,113,280, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
lots N4D0328KX N4D0338KX N4E0796KX N4E0846KX N4E0980KX N4E1018KX N4E1059KX N4E1173KX N4E1269KX N4E1654KX N4E1655KX N4G0523KX N4G1541KX N4H0078KX N4J0215KX N4J0250KX N4J0271KX N4J1002KX N4J1217KX N4J1247KX N4K1465KX N4M0921KX N5B0285KX…
Every code shown here, 1,996 characters
lots N4D0328KX N4D0338KX N4E0796KX N4E0846KX N4E0980KX N4E1018KX N4E1059KX N4E1173KX N4E1269KX N4E1654KX N4E1655KX N4G0523KX N4G1541KX N4H0078KX N4J0215KX N4J0250KX N4J0271KX N4J1002KX N4J1217KX N4J1247KX N4K1465KX N4M0921KX N5B0285KX N5B0340KX N5B0417KX N5B0484KX N5B0680KX N5D0467KX N5D0497KX N5D0550KX N5D0609KX N5D0660KX N5D0736KX N5D0765KX N5D1008KX N5E0068KX N5E0143KX N5E0297KX N5E0727KX N5E0756KX N5F0096KX N5F1223KX N5F1382KX N5G0244KX N5G0329KX N5G0339KX N5G0355KX N5G0405KX N5G0414KX N5G0809KX N5G0868KX N5J1153KX N5J1201KX N5J1233KX N5K0045KX N5K0089KX N5K0115KX N5M0172KX N5M0662KX N5M0693KX N5M0732KX N5M0741KX N6A0913KX N6B0332KX N6C0462KX N6D0388KX N6D0474KX N6D0506KX N6E0078KX N6E0099KX N6E0117KX N6E0129KX N6E0366KX N6E0416KX N6F0039KX N6F0088KX N6F0156KX N6F0720KX N6F0780KX N6F0816KX N6G0099KX N6G0139KX N6G0191KX N6G0198KX N6G0213KX N6G0243KX N6G0280KX N6H0168KX N6H0247KX N6H0291KX N6H0327KX N6H0370KX N6H0433KX N6H0456KX N6H0466KX N6H0792KX N6H0827KX N6J0152KX N6J0185KX N6J0243KX N6J0476KX N6K0160KX N6K0209KX N6K0251KX N6K0293KX N6K0676KX N6K0739KX N6K0774KX N6K0824KX N6K0871KX N6K1137KX N6L0806KX N6L0814KRX N6L0909KX N6L0942KX N6L0944KX N6M0065KX N6M0095KX N6M0113KX N6M0134KX N6M0263KX N7A0293KX N7A0792KX N7B0070KX N7B0125KX N7B0154KX N7B0177KX N7B0885KX N7B0905KX N7B0946KX N7C0387KX N7C0405KX N7C0442KX N7C0485KX N7C0517KX N7C0775KX N7C0812KX N7C0857KX N7C0899KX N7C0927KX N7C0977KX N7C1014KX N7D0101KX N7D0135KX N7D0182KX N7D0226KX N7D0247KX N7D0264KX N7D0416KX N7D0473KX N7D0495KX N7D0538KX N7D0591KX N7D0918KX N7D0945KX N7E0372KX N7E0518KX N7E0565KX N7E0610KX N7E0920KX N7E0962KX N7F0093KX N7F0094KX N7F0186KX N7F0224KX N7F0662KX N7F0663KX N7F0696KX N7F0745KX N7F0822KX N7F1019KX N7F1052KX N7F1139KX N7G0016KX N7G0241KX N7G0279KX N7G0498KX N7G0790KX N7G0904KX N7H0012KX N7H0174KX N7H0315KX N7H0347KX N7H0419KX N7H0470KX N7H0520KX N7H0569KX N7H0712KX N7H0786KX N7H0957KX N7H1017KX N7H1057KX N7H1096KX N7H1141KX N7H1175KX N7H1187KX N7J0070KX N7J0099KX N7J0135KX…
FDA’s list runs to 3,568 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.
Nationwide domestic distribution, worldwide foreign 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 May 17, 2019.
- FDA classified it on Jun 15, 2019.
- FDA’s Enforcement Report published it on Jun 26, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Covidien LLC, 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.”
- FDA’s list of codes runs to 3,568 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.