EGIA 60 ARTICULATING MED THICK SULU , EGIA60AMT
Medical device recall Z-1829-2019. 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 60 ARTICULATING MED THICK SULU , EGIA60AMT
3,113,280, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
N4C1545KX N4C1718KX N4D0042KX N4D0366KX N4D0453KX N4D0589KX N4D0605KX N4D0688KX N4D0814KX N4D0897KX N4D1145KX N4E1383KX N4E1505KX N4F0006KX N4F0076KX N4F0114KX N4F0516KX N4F0695KX N4F0719KX N4F0853KX N4F0929KX N4F0981KX N4F1092KX N4F1159KX…
Every code shown here, 1,992 characters
N4C1545KX N4C1718KX N4D0042KX N4D0366KX N4D0453KX N4D0589KX N4D0605KX N4D0688KX N4D0814KX N4D0897KX N4D1145KX N4E1383KX N4E1505KX N4F0006KX N4F0076KX N4F0114KX N4F0516KX N4F0695KX N4F0719KX N4F0853KX N4F0929KX N4F0981KX N4F1092KX N4F1159KX N4F1163KX N4F1331KX N4F1383KX N4F1450KX N4F1542KX N4H0432KX N4H0475KX N4H0503KX N4J1170KX N4K0212KX N4K0742KX N4K0757KX N4K0835KX N4K0870KX N4L0249KX N4L0315KX N4M0982KX N4M1062KX N5A0286KX N5A0345KX N5A0364KX N5A1461KX N5B0031KX N5B0700KX N5B0757KX N5B0794KX N5B0856KX N5C0465KX N5C0639KX N5C0668KX N5C0725KX N5C0758KRX N5C0914KX N5C0986KX N5D0862KX N5E0348KX N5E1158KX N5E1213KX N5E1245KX N5F0181KX N5F0260KX N5F0330KX N5F0348KX N5G0114KX N5G0154KX N5G0186KX N5G0660KX N5G0877KX N5G0983KX N5G1011KX N5G1122KX N5G1147KX N5G1248KX N5H0100KX N5H0226KX N5H0250KX N5H0481KX N5H0623KX N5H0676KX N5H0730KX N5H0762KX N5H0838KX N5H0949KX N5H0970KX N5H0993KX N5H1013KX N5H1082KX N5H1111KX N5H1158KX N5H1186KX N5H1216KX N5J0220KX N5J0266KX N5J0295KX N5J0321KX N5J0418KX N5J0492KX N5J0512KX N5J0532KX N5J0572KX N5J0658KX N5J0694KX N5J0775KX N5J0816KX N5J0966KX N5J1099KX N5J1130KX N5K0139KX N5K0208KX N5K0308KX N5K0374KX N5K0412KX N5K0429KX N5K0564KX N5K0595KX N5K0629KX N5K0665KX N5K0700KX N5K0732KX N5K0775KX N5K0848KX N5K0895KX N5K0941KX N5K0992KX N5K1054KX N5L0595KX N5L0673KRX N5L0746KX N5L0809KX N5M0088KX N5M0150KX N5M0459KX N5M0491KX N5M0536KX N5M0582KX N5M0632KX N5M0769KX N5M0827KX N6A0004KX N6A0034KX N6A0086KX N6A0124KX N6A0253KX N6A0255KX N6A0428KX N6A0520KX N6A0527KX N6B0028KX N6B0052KX N6B0081KX N6B0105KX N6B0135KX N6B0177KX N6B0219KX N6B0270KX N6B0323KX N6B0386KX N6B0405KX N6B0477KX N6B0504KX N6B0541KX N6B0624KX N6B0722KX N6B0746KX N6B0788KX N6B0852KX N6B0923KX N6C0355KX N6C0369KX N6C0370KX N6C0398KX N6C0509KX N6C0524KX N6C0562KX N6C0589KX N6C0598KX N6C0678KX N6C0701KX N6C0737KX N6C0753KX N6C0800KX N6C0841KX N6C0889KX N6C0913KX N6C0938KX N6C0972KX N6D0009KX N6D0051KX N6D0070KX N6D0091KX N6D0160KX N6D0180KX N6D0230KX N6D0283KX N6D0285KX…
FDA’s list runs to 5,872 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 5,872 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.