CLASS II Device recall · Reported 23 May 2018 · FDA Enforcement Report

Covidien" Best Practices" Procedure Kits recalled by Covidien Medtronic

Covidien Medtronic is recalling Covidien" Best Practices" Procedure Kits containing Auto Suture" Endo GIA" Devices, distributed nationwide in the US. The recall was initiated on 26 Apr 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes00Z2403, 00Z2293, 00Z2200, 00Z2745, 00Z2650, 00Z2648, 00Z2429, 00Z2287, 00Z2117, 00Z2482, 00Z2582, 00Z2096, 00Z2273, 00Z2544, 00Z2577A, 00Z2366, 00Z2689, 00Z2408, 00Z2707, SIGEVAL4, 00Z2516, 00Z2450, 00Z2651, 00Z2706, 00Z2117, IDRIVEXLAMTAXT, 00Z2610, 00Z2419, 00Z2451, IDRIVEXLAMT, 00Z2286, 00Z2556, 00Z2452, 00Z2201 & ADAPTRE12

Quantity recalled171,271 units in total

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-1824-2018
FDA event ID: 79974
Recalling firm: Covidien Medtronic, NORTH HAVEN, CT
Classification: Class II
Status: Terminated
Recall initiated: 26 Apr 2018
FDA classified: 6 Jul 2018
Reported: 23 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Surgical Instruments

Timeline

26 Apr 2018	Recall initiated by company
23 May 2018	Published in enforcement report	+27 days
6 Jul 2018	Classified by FDA	+44 days

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

Reason for recall

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

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

Covidien" Best Practices" Procedure Kits containing Auto Suture" Endo GIA" Devices Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.

Where it was distributed

Worldwide and US Nationwide

Nationwide

Questions about this recall

Is Covidien" Best Practices" Procedure Kits containing Auto Suture" Endo GIA" Devices recalled?

Yes. Covidien Medtronic recalled Covidien" Best Practices" Procedure Kits containing Auto Suture" Endo GIA" Devices on 26 Apr 2018. The recall is Class II and its status is Terminated. Recall number Z-1824-2018.

Why was it recalled?

Which lots are affected?

00Z2403, 00Z2293, 00Z2200, 00Z2745, 00Z2650, 00Z2648, 00Z2429, 00Z2287, 00Z2117, 00Z2482, 00Z2582, 00Z2096, 00Z2273, 00Z2544, 00Z2577A, 00Z2366, 00Z2689, 00Z2408, 00Z2707, SIGEVAL4, 00Z2516, 00Z2450, 00Z2651, 00Z2706, 00Z2117, IDRIVEXLAMTAXT, 00Z2610, 00Z2419, 00Z2451, IDRIVEXLAMT, 00Z2286, 00Z2556, 00Z2452, 00Z2201 & ADAPTRE12

Where was it sold?

Worldwide and US Nationwide

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

More recalls from Covidien Medtronic

All 55

Reported	Class	Recall	Company	Reason	Where
25 Jul 2018Device	CLASS II	Tri-Staple 0 Black Intelligent Reload for use recalled	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018Device	CLASS II	Endo GIA Curved Tip Articulating Vascular/Medium Reload recalled	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018Device	CLASS II	Tri-Staple 0 Intelligent Reload for use recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018Device	CLASS II	Tri-Staple 0 Curved Tip Intelligent Reload for use recalled	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018Device	CLASS II	Endo GIA Extra Thick Black Articulating Reload recalled	Covidien Medtronic	Packaging Defects	Nationwide

Other Surgical Instruments recalls

All 3,809

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2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
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2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide