CLASS II ONGOING Device recall · Reported 26 Jun 2019 · FDA Enforcement Report

Egia 30 Articulating Med Thick Sulu recalled by Covidien

Covidien is recalling Egia 30 Articulating Med Thick Sulu, distributed nationwide in the US. The recall was initiated on 17 May 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codeslots N5A0871KX N7A0527KX N7E0441KX N8J0039KX N8J0527KX N8J0820KX

Quantity recalled3,113,280

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1825-2019
FDA event ID: 82950
Recalling firm: Covidien, North Haven, CT
Classification: Class II
Status: Ongoing
Recall initiated: 17 May 2019
FDA classified: 15 Jun 2019
Reported: 26 Jun 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

17 May 2019	Recall initiated by company
15 Jun 2019	Classified by FDA	+29 days
26 Jun 2019	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

EGIA 30 ARTICULATING MED THICK SULU, Item Code EGIA30AMT

Where it was distributed

Nationwide domestic distribution, worldwide foreign distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

lots N5A0871KX N7A0527KX N7E0441KX N8J0039KX N8J0527KX N8J0820KX

Where was it sold?

Nationwide domestic distribution, worldwide foreign distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

11 other products · FDA event 82950

This product is part of a recall event; the main page for the event is Egia 45 Articulating Xtra Thick Sulu recalled by Covidien.

Reported	Class	Recall	Company	Reason	Where
26 Jun 2019	CLASS II	Egia 45 Articulating Xtra Thick Sulu recalled by Covidien	Covidien	Packaging Defects	Nationwide
26 Jun 2019	CLASS II	Signia Tri-staple 2.0 Curved Tip Medium/ Thic , Sig45ctamt recalled	Covidien	Packaging Defects	Nationwide
26 Jun 2019	CLASS II	Signia Tri-staple 2.0 Medium/ Thick Reload , Sig30amt recalled	Covidien	Packaging Defects	Nationwide
26 Jun 2019	CLASS II	Egia 45 Articulating Med Thick Sulu recalled by Covidien	Covidien	Packaging Defects	Nationwide
26 Jun 2019	CLASS II	Signia Tri-staple 2.0 Black Extra Thick Reloa, Sig60axt recalled	Covidien	Packaging Defects	Nationwide
26 Jun 2019	CLASS II	Egia 60 Curved Tip Art Med Thick Sulu, Egia60ctamt recalled by Covidien	Covidien	Packaging Defects	Nationwide
26 Jun 2019	CLASS II	Egia 60 Articulating Extra Thick Sulu recalled by Covidien	Covidien	Packaging Defects	Nationwide
26 Jun 2019	CLASS II	Signia Tri-staple 2.0 Curved Tip Medium/ Thic , Sig60ctamt recalled	Covidien	Packaging Defects	Nationwide
26 Jun 2019	CLASS II	Signia Tri-staple 2.0 Black Extra Thick Reloa, Sig45axt recalled	Covidien	Packaging Defects	Nationwide
26 Jun 2019	CLASS II	Egia 60 Articulating Med Thick Sulu , Egia60amt recalled by Covidien	Covidien	Packaging Defects	Nationwide
26 Jun 2019	CLASS II	Egia45 CT Ar Md Thk Rel, Egia45ctamt recalled by Covidien	Covidien	Packaging Defects	Nationwide

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All 493

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