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

Box Vwr Zestaw Do Vats Klin recalled by Covidien Medtronic

Covidien Medtronic is recalling Box Vwr Zestaw Do Vats Klin, 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 codesLots:0215122344

Quantity recalled169,775 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-1866-2018
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

BOX VWR ZESTAW DO VATS KLIN 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

Why was it recalled?

Which lots are affected?

Lots:0215122344

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 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

39 other products · FDA event 79974

This product is part of a recall event; the main page for the event is Box Tgglogowx1 Do Total Gastrectomiii recalled by Covidien Medtronic.

Reported	Class	Recall	Company	Reason	Where
23 May 2018	CLASS II	Box Tgglogowx1 Do Total Gastrectomiii recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box Zestaw Do Hemicolectomii recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box Lapzd Zestaw Do Sg Box Zestaw Do Sg Box Lapisgw Zestaw Do Sg recalled	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box Kit00713 Kit By Pass recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box Pst03699 Kit App Med Alternativ Stap recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box Pst03533 Kit App Stapler recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box Kit1171c Kit Lap Cystectomy recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Endo GIA" Gray Curved Tip Articulating Vascular Reload recalled	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Endo GIA" Gray Curved Tip Articulating Vascular Reload recalled	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box Kit1095v Kit Obesitas recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Endo GIA" Auto Suture" Universal Articulating Loading Unit recalled	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Endo GIA" Gray Curved Tip Articulating Vascular Reload recalled	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box Sleeve Aiwa Clinic recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box Vats1scdx Do Zabiegow Vats recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Endo GIA" Auto Suture" Universal Articulating Loading Unit recalled	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box Vmin Zestaw Do Vats Podstawowy recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box Kitde0108 Bypass Kit Luebeck ( Kitde0108) recalled	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Apen Lobectomy Kit X0 recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Kit-de-0080 Bypass Kit Lohne X1 recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box Bypass Box recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box Mgbglogx1 Zestaw Mini Gastric Bypass recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box Sleeve Gastrectomy Box Sleevejawi Sleeve Gastrectomy recalled	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Endo GIA" Auto Suture" Universal Articulating Loading Unit recalled	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Endo GIA" Auto Suture" Universal Articulating Loading Unit recalled	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Sleevegk1 Zestaw Do Zabiegow Sleevex1 recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Kit00486r Obesidad D recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Covidien" Best Practices" Procedure Kits recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Endo GIA" Auto Suture" Universal Articulating Loading Unit recalled	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Mgbx Zestaw Gb Ls X1 recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box Appendix Lippe Detmold Appenektomie Kit recalled	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box Bariatric Tristaple recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box 01kbar006116v Proc Bypass 01kbar0061 recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box Lapimbgp1 Zestaw Do Mgbp (lapimbgp1) recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box Kit00714 Kit Sleeve recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Lapbarleczna Zestaw Bariatryczny Leczna- Bariatric Kit X1 recalled	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box Appendix Kit Zams recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Box1073076gasb1 Bbr Gastric Bypass S recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Endo GIA" Auto Suture" Universal Articulating Loading Unit recalled	Covidien Medtronic	Packaging Defects	Nationwide
23 May 2018	CLASS II	Endo GIA" Auto Suture" Universal Articulating Loading Unit recalled	Covidien Medtronic	Packaging Defects	Nationwide

More recalls from Covidien Medtronic

All 55

Reported	Class	Recall	Company	Reason	Where
25 Jul 2018Device	CLASS II	Tri-Staple 2.0 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 2.0 Intelligent Reload for use recalled by Covidien Medtronic	Covidien Medtronic	Packaging Defects	Nationwide
25 Jul 2018Device	CLASS II	Tri-Staple 2.0 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

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide